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Beckman Coulter Inc. - AQUIOS CL Flow Cytometer System - Class 2 Recall
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 20, 2017 Category: Medical Devices Source Type: alerts

Biomerieux Inc - VITEK 2 GP ID Test card - Class 2 Recall
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2017 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corp - Baxter Amia Automated Peritoneal Dialysis Set with Cassette - Class 2 Recall
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2017 Category: Medical Devices Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - Class 2 Recall
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2017 Category: Medical Devices Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - Class 2 Recall
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2017 Category: Medical Devices Source Type: alerts

Mako Surgical Corporation - Total Hip Application (THA) - Class 2 Recall
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2017 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - FFR LinkFFR Signal Processing Module - Class 2 Recall
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2017 Category: Medical Devices Source Type: alerts

Mako Surgical Corporation - Makoplasty Partial Knee Application (PKA) - Class 2 Recall
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2017 Category: Medical Devices Source Type: alerts

X-Laser Llc - Aurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and Hawk 500 models - Class 2 Recall
X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Sekure Chemistry Acetaminophen L3K - Class 2 Recall
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

Leica Biosystems Richmond Inc. - MSH6 (44 Mab) CM - Class 2 Recall
Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

bioMerieux, Inc. - eMAG System - Class 2 Recall
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

Leica Biosystems Richmond Inc. - Napsin A (MRQ60 Mab) CM - Class 2 Recall
Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - Herga foot switch, a component of ROSA Surgical Device - Class 2 Recall
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standa...
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

Leica Biosystems Richmond Inc. - SOX10 (Polyclonal) CM - Class 2 Recall
Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

Leica Biosystems Richmond Inc. - Microphthalmia Transcription Factor - Class 2 Recall
Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

Leica Biosystems Richmond Inc. - Glypican3 (1G12 Mab) CM - Class 2 Recall
Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

Leica Biosystems Richmond Inc. - Podoplanin (D240) antibody - Class 2 Recall
Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

Leica Biosystems Richmond Inc. - PAX8 (MRQ50 Mab) CM - Class 2 Recall
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

Leonhard Lang Medizintechnik GmbH - Skintact Multifunction Electrodes - Class 1 Recall
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2017 Category: Medical Devices Source Type: alerts

Becton Dickinson & Company - BD Needle 22GA 11/2in SafetyGlide(TM) - Class 2 Recall
BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needle stick prevention feature of the device contains a mechanism that covers the needlepoint after use. Bulk Non Sterile configuration is intended for further manufacturing, processing or repackaging (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2017 Category: Medical Devices Source Type: alerts

Toshiba American Medical Systems - Radrex i - Class 2 Recall
Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and trans mission/ output of images to external devices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2017 Category: Medical Devices Source Type: alerts

Implant Direct Sybron Manufacturing, LLC - Guided Handle Kit - Class 2 Recall
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - COULTER Hematology Analyzers: LH 750; LH 500, and LH 780 - Class 2 Recall
Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further me...
Source: Medical Device Recalls - September 8, 2017 Category: Medical Devices Source Type: alerts

Qualigen Inc - Qualigen FastPack IP Vitamin D Immunoassay Kit Complete - Class 2 Recall
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 8, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - COULTER HmX Hematology Analyzer - Class 2 Recall
Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 8, 2017 Category: Medical Devices Source Type: alerts

Elekta, Inc. - MOSAIQ Oncology Information System - Class 2 Recall
MOSAIQ Medical Charged-Particle Radiation Therapy System (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2017 Category: Medical Devices Source Type: alerts

CryoLife, Inc. - OnX Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft - Class 2 Recall
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2017 Category: Medical Devices Source Type: alerts

Maquet Datascope Corp - Cardiac Assist Division - CS 100 IntraAortic Balloon Pump - Class 1 Recall
CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 6, 2017 Category: Medical Devices Source Type: alerts

Maquet Datascope Corp - Cardiac Assist Division - CS 100i IntraAortic Balloon Pump - Class 1 Recall
CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 6, 2017 Category: Medical Devices Source Type: alerts

Maquet Datascope Corp - Cardiac Assist Division - CS 300 IntraAortic Balloon Pump - Class 1 Recall
CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 6, 2017 Category: Medical Devices Source Type: alerts

Stanmore Implants Worldwide Ltd. - JTS External Drive Unit (JTS Grower Drive) - Class 2 Recall
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 6, 2017 Category: Medical Devices Source Type: alerts

Microvention, Inc. - Traxcess 7 Mini Guidewire - Class 2 Recall
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 2, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Beckman Coulter Slidemaker Stainer - Class 2 Recall
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and ai...
Source: Medical Device Recalls - September 2, 2017 Category: Medical Devices Source Type: alerts

Encore Medical, Lp - Turon Glenoid Reamer - Class 2 Recall
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 1, 2017 Category: Medical Devices Source Type: alerts

Toshiba American Medical Systems Inc - Ultimax Digital Fluoroscopic XRay System - Class 2 Recall
Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 31, 2017 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar) - Class 2 Recall
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis Q.zen biplane - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis zee biplane MN - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis zee floor - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis zeego - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis zee ceiling - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis Q. zen ceiling - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Med Tec Inc - CIVCO Arm Support - Class 2 Recall
CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis zeego.Q - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis Q floor - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis Q. zen floor - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis zee multipurpose - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis zee floor MN - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis zee biplane - Class 2 Recall
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of...
Source: Medical Device Recalls - August 30, 2017 Category: Medical Devices Source Type: alerts