syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgr...
Reason: Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed i...
Z-0995-2022May 4, 2022Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgr...
Reason: Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed i...
Z-0996-2022May 4, 2022Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A afte...
Reason: Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed i...
Z-0997-2022May 4, 2022Malvern, PA
Roche Diabetes Care, Inc.
Class IITerminated
RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.
Reason: Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
Z-1008-2022May 4, 2022Indianapolis, IN
Medtronic Neuromodulation
Class IIOngoing
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) Inte...
Reason: There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost"...
Z-0998-2022May 4, 2022Minneapolis, MN
Baxter Healthcare Corporation
Class IIOngoing
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Reason: This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limi...
Z-0993-2022May 4, 2022Deerfield, IL
Baxter Healthcare Corporation
Class IIOngoing
PrisMax System, Product Code 955626
Reason: This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limi...
Z-0991-2022May 4, 2022Deerfield, IL
Siemens Medical Solutions USA, Inc
Class IITerminated
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Reason: Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed i...
Z-0994-2022May 4, 2022Malvern, PA
Siemens Medical Solutions USA, Inc
Class IIOngoing
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
Reason: Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential softwar...
Z-0986-2022April 27, 2022Malvern, PA
Medtronic Xomed, Inc.
Class IITerminated
Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number E...
Reason: As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect ...
Z-0961-2022April 27, 2022Jacksonville, FL
Siemens Medical Solutions USA, Inc
Class IIOngoing
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Reason: Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential softwar...
Z-0987-2022April 27, 2022Malvern, PA
St. Jude Medical, Cardiac Rhythm Management Division
Class IIOngoing
Merlin 2 PCS MER3700 programmer Model MER3400 software
Reason: Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchroniza...
Z-0965-2022April 27, 2022Sylmar, CA
St. Jude Medical, Cardiac Rhythm Management Division
Class IIOngoing
Merlin PCS 3650 programmer Model 3330 software
Reason: Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchroniza...
Reason: Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur d...
Z-0962-2022April 27, 2022Malvern, PA
Siemens Medical Solutions USA, Inc
Class IIOngoing
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
Reason: Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential softwar...
Z-0985-2022April 27, 2022Malvern, PA
SIGHT DIAGNOSTICS LTD
Class IIOngoing
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., re...
Reason: In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on sof...
Reason: Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
Z-0942-2022April 20, 2022Baden, N/A
Volcano Corporation
Class IIOngoing
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Reason: If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be dis...
Reason: Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown ...
Z-0874-2022April 13, 2022Cambridge, MA
Philips Healthcare
Class IITerminated
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Reason: Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live pr...
Z-0737-2022April 13, 2022Andover, MA
Remote Diagnostic Technologies Ltd.
Class IITerminated
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Reason: Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Z-0861-2022April 13, 2022Basingstoke
Draeger Medical, Inc.
Class IITerminated
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Reason: Cybersecurity Improvement Action-not equipped against potential cyber security threats
Z-0870-2022April 13, 2022Telford, PA
Draeger Medical, Inc.
Class IITerminated
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 ...
Reason: Cybersecurity Improvement Action-not equipped against potential cyber security threats
Z-0871-2022April 13, 2022Telford, PA
Diagnos Inc
Class IITerminated
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Reason: Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prio...
Z-0826-2022April 6, 2022Brossard, N/A
RaySearch America Inc
Class IIOngoing
RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6...
Reason: Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.