Alinity ci-series System Control Module, REF: 03R70-01
Reason: There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sa...
Z-0613-2024January 3, 2024Irving, TX
Philips North America Llc
Class IICompleted
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system a...
Reason: Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical ...
Reason: Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When t...
Z-0601-2024December 27, 2023Norwood, MA
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Reason: During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface...
Z-0546-2024December 20, 2023Rochester, NY
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
Reason: During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface...
Z-0545-2024December 20, 2023Rochester, NY
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Reason: During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface...
Z-0547-2024December 20, 2023Rochester, NY
Medtronic Inc.
Class IICompleted
Medtronic SynchroMed, Model A10
Reason: The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Cath...
Z-0522-2024December 20, 2023Mounds View, MN
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Reason: During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface...
Z-0544-2024December 20, 2023Rochester, NY
Bebig Isotopentechnik Gmbh
Class IIOngoing
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Reason: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
Z-0517-2024December 20, 2023Berlin, N/A
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
Reason: During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface...
Z-0543-2024December 20, 2023Rochester, NY
Abiomed, Inc.
Class IITerminated
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Reason: Pump not detected as connected to controller due to software issue.
Reason: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Z-0448-2024December 13, 2023Redwood City, CA
Abiomed, Inc.
Class IITerminated
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Reason: Pump not detected as connected to controller due to software issue.
Z-0441-2024December 13, 2023Danvers, MA
LEONI CIA CABLE SYSTEMS
Class IIOngoing
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Numb...
Reason: Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again a...
Z-0398-2024November 29, 2023Chartres, N/A
LEONI CIA CABLE SYSTEMS
Class IIOngoing
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Numb...
Reason: Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again a...
Z-0399-2024November 29, 2023Chartres, N/A
Philips North America Llc
Class IIOngoing
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
Reason: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using i...
Z-0293-2024November 22, 2023Cambridge, MA
Philips North America
Class IIOngoing
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Reason: This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move t...
Z-0319-2024November 22, 2023Cambridge, MA
Philips North America
Class IIOngoing
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Reason: When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to b...
Z-0306-2024November 22, 2023Cambridge, MA
Philips North America Llc
Class IIOngoing
Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
Reason: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using i...
Z-0294-2024November 22, 2023Cambridge, MA
Philips North America Llc
Class IIOngoing
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Reason: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using i...
Z-0292-2024November 22, 2023Cambridge, MA
CHANGE HEALTHCARE CANADA COMPANY
Class IIOngoing
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
Reason: Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.
Z-0237-2024November 15, 2023Richmond
Carestream Health, Inc.
Class IIOngoing
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), im...
Reason: There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This c...
Z-0289-2024November 15, 2023Rochester, NY
Medtronic Navigation, Inc.
Class IOngoing
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in eithe...
Reason: Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.