Roche Diagnostics Corporation - cobas e 411 Immunoassay Analyzer - Class 2 Recall
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2018 Category: Medical Devices Source Type: alerts
Roche Diagnostics Corporation - Roche / Hitachi MODULAR Analyzer Systems - Class 2 Recall
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare Ingenuity Core - Class 2 Recall
Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare Brilliance iCT - Class 2 Recall
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare Brilliance 64 - Class 2 Recall
Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare Ingenuity Core 128 - Class 2 Recall
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2018 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - UniCel DxH 600 Coulter Cellular Analysis System - Class 2 Recall
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities) (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 14, 2017 Category: Medical Devices Source Type: alerts
ICU Medical Inc - ICU Mednet(TM) Medication Management Suite 6.1 and 6.21 - Class 2 Recall
ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way t...
Source: Medical Device Recalls - December 7, 2017 Category: Medical Devices Source Type: alerts
Zimmer Biomet, Inc. - ComputerAssisted Surgical Device - Class 2 Recall
ROSA Surgical Device 2.5.8 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 standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2017 Category: Medical Devices Source Type: alerts
Zimmer Biomet, Inc. - Computer Assisted Surgical Device - Class 2 Recall
ROSA Surgical Device 2.5.8 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2017 Category: Medical Devices Source Type: alerts
Zimmer Biomet, Inc. - ROSA Spine 1.0.2 - Class 2 Recall
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumber vertebrae with a posterior approach. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2017 Category: Medical Devices Source Type: alerts
Zimmer Biomet, Inc. - ComputerAssisted Surgical Device - Class 2 Recall
ROSA Surgical Device 2.5.8 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 standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2017 Category: Medical Devices Source Type: alerts
Zimmer Biomet, Inc. - ComputerAssisted Surgical Device - Class 2 Recall
ROSA Brain 3.0.0 Usage: 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 - November 22, 2017 Category: Medical Devices Source Type: alerts
Zimmer Biomet, Inc. - ROSA ComputerAssisted Surgical Device - Class 2 Recall
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 21, 2017 Category: Medical Devices Source Type: alerts
Zimmer Biomet, Inc. - ComputerAssisted Surgical Device - Class 2 Recall
ROSA BRAIN 3.0.0 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2017 Category: Medical Devices Source Type: alerts
