Neusoft Medical Systems Co., Ltd. - NeuViz 128 CT Scanner System - Class 2 Recall
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2017 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Medtronic ENT Prgm Add Fusion Nav AxiEM - Class 2 Recall
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coi...
Source: Medical Device Recalls - August 22, 2017 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Medtronic Instrument Set EM ENT - Class 2 Recall
Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical...
Source: Medical Device Recalls - August 22, 2017 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Medtronic Curved Suction 70 - Class 2 Recall
Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation ...
Source: Medical Device Recalls - August 22, 2017 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Medtronic Suction Small AxiEM ENT - Class 2 Recall
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation o...
Source: Medical Device Recalls - August 22, 2017 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Medtronic Set Supplemental INS AxiEM ENT - Class 2 Recall
Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength...
Source: Medical Device Recalls - August 22, 2017 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Medtronic Straight Suction - Class 2 Recall
Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation o...
Source: Medical Device Recalls - August 22, 2017 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Medtronic Curved Suction 90 - Class 2 Recall
Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation ...
Source: Medical Device Recalls - August 22, 2017 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Medtronic Instrument Kit Fusion ENT - Class 2 Recall
Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each sur...
Source: Medical Device Recalls - August 22, 2017 Category: Medical Devices Source Type: alerts
Zimmer Biomet, Inc. - ComputerAssisted Surgical Device - Class 2 Recall
ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 4, 2017 Category: Medical Devices Source Type: alerts
Soft Computer Consultants, Inc. - SoftLab - Class 2 Recall
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 2, 2017 Category: Medical Devices Source Type: alerts
Pentax of America Inc - Digital Video Capture Modules - Class 2 Recall
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 19, 2017 Category: Medical Devices Source Type: alerts
Merge Healthcare, Inc. - Merge Eye Care PACS Viewer 5.2 - Class 2 Recall
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected ...
Source: Medical Device Recalls - July 11, 2017 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - AXIOM Sensis Vibe Systems - Class 2 Recall
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer, (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 7, 2017 Category: Medical Devices Source Type: alerts
Orthosoft, Inc. dba Zimmer CAS - Sesamoid Plasty - Class 2 Recall
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2017 Category: Medical Devices Source Type: alerts
