ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Reason: Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communic...
Z-0271-2022December 1, 2021Irving, TX
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IIOngoing
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization...
Reason: The processing of collected episode data may fail due to a software error.
Z-0282-2022December 1, 2021Mounds View, MN
Philips Healthcare
Class IIOngoing
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Reason: 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability...
Z-0238-2022December 1, 2021Andover, MA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may...
Z-0297-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
Reason: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay i...
Z-0289-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IIOngoing
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administr...
Reason: System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more th...
Z-0226-2022November 24, 2021Malvern, PA
Baxter Healthcare Corporation
Class IIOngoing
Hemodialysis Delivery System, Software Version 2.x.
Reason: If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the syst...
Reason: When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table ...
Z-0213-2022November 17, 2021Cambridge, MA
Medtronic Neuromodulation
Class IIOngoing
Clinician Programmer Application (CPA) model A610 Clinician Software Application
Reason: A software anomaly may occur with the clinician programmer application.
Z-0201-2022November 10, 2021Minneapolis, MN
FujiFilm Healthcare Americas Corporation
Class IIOngoing
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Reason: When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area ...
Z-0192-2022November 10, 2021Twinsburg, OH
FujiFilm Healthcare Americas Corporation
Class IIOngoing
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Reason: Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results corr...
Z-0189-2022November 10, 2021Twinsburg, OH
FujiFilm Healthcare Americas Corporation
Class IIOngoing
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Reason: Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results corr...
Z-0190-2022November 10, 2021Twinsburg, OH
Siemens Medical Solutions USA, Inc
Class IIOngoing
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 102810...
Reason: Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause t...
Z-0200-2022November 10, 2021Malvern, PA
FujiFilm Healthcare Americas Corporation
Class IIOngoing
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Reason: Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results corr...
Z-0191-2022November 10, 2021Twinsburg, OH
AB SCIEX
Class IITerminated
Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288
Reason: The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. ...
Z-0175-2022November 3, 2021Concord, N/A
Xstrahl Limited
Class IITerminated
Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - ...
Reason: If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages...
Z-0174-2022November 3, 2021Walsall, N/A
MEDTECH SAS
Class IOngoing
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical ins...
Reason: The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received...
Z-0118-2022November 3, 2021Montpellier, N/A
Canon Medical System, USA, INC.
Class IITerminated
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Reason: A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is s...
Reason: Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatme...
Z-0123-2022October 27, 2021Bothell, WA
Medtronic Xomed, Inc.
Class IIOngoing
Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ...
Reason: There was an increase in complaints related to tip breaks and wobble/vibration.
Z-0158-2022October 27, 2021Jacksonville, FL
Medtronic Xomed, Inc.
Class IIOngoing
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ...
Reason: There was an increase in complaints related to tip breaks and wobble/vibration.
Z-0157-2022October 27, 2021Jacksonville, FL
Medtronic Xomed, Inc.
Class IIOngoing
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ...
Reason: There was an increase in complaints related to tip breaks and wobble/vibration.
Z-0156-2022October 27, 2021Jacksonville, FL
Draeger Medical, Inc.
Class IIOngoing
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Reason: Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 sec...
Z-0108-2022October 20, 2021Telford, PA
Draeger Medical, Inc.
Class IIOngoing
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) ...
Reason: Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 sec...
Z-0109-2022October 20, 2021Telford, PA
GE Healthcare, LLC
Class IITerminated
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Reason: A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or ...