Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Z-0914-2023January 18, 2023Minneapolis, MN
Roche Diagnostics Operations, Inc.
Class IIOngoing
cobas infinity central lab, Material Number 07154003001
Reason: A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order receiv...
Z-0952-2023January 18, 2023Indianapolis, IN
Siemens Medical Solutions USA, Inc
Class IIOngoing
Programmable Diagnostic Computer
Reason: The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSW...
Z-0775-2023January 11, 2023Malvern, PA
Fresenius Medical Care Holdings, Inc.
Class IIOngoing
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 ...
Reason: (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference...
Z-0734-2023December 28, 2022Waltham, MA
Siemens Medical Solutions USA, Inc
Class IIOngoing
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and ele...
Reason: When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
Z-0472-2023December 21, 2022Malvern, PA
Elekta, Inc.
Class IIOngoing
Oncentra Brachy radiation therapy planning system software.
Reason: A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Z-0719-2023December 21, 2022Atlanta, GA
Mobius Imaging, LLC
Class IITerminated
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Reason: Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitorin...
Z-0344-2023December 7, 2022Shirley, MA
Smiths Medical ASD Inc.
Class IIOngoing
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infu...
Reason: Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
Z-0272-2023November 30, 2022Minneapolis, MN
Abbott Molecular, Inc.
Class IIOngoing
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Reason: Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when t...
Z-0268-2023November 30, 2022Des Plaines, IL
X-NAV Technologies, LLC
Class IIOngoing
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Reason: Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into ...
Z-0222-2023November 16, 2022Lansdale, PA
Boston Scientific Corporation
Class IIOngoing
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Reason: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Z-0151-2023November 9, 2022Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Reason: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Z-0152-2023November 9, 2022Saint Paul, MN
Siemens Medical Solutions USA, Inc
Class IIOngoing
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Reason: Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment c...
Z-0119-2023November 2, 2022Malvern, PA
Fresenius Kabi USA, LLC
Class ITerminated
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Reason: The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. Howe...
Z-0002-2023October 12, 2022North Andover, MA
Tandem Diabetes Care Inc
Class IIOngoing
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Reason: Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open L...
Z-1811-2022October 5, 2022San Diego, CA
Micro-X Ltd.
Class IIOngoing
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Reason: Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiatio...
Z-1786-2022October 5, 2022Tonsley, N/A
Tandem Diabetes Care Inc
Class IIOngoing
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Reason: Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open L...
Z-1812-2022October 5, 2022San Diego, CA
DICOM Grid, Inc. d/b/a Ambra Health
Class IIOngoing
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Reason: A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.
Z-1818-2022October 5, 2022New York, NY
Leica Microsystems, Inc.
Class IIOngoing
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Reason: During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment o...
Z-1848-2022October 5, 2022deerfield, IL
Leica Microsystems, Inc.
Class IIOngoing
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
Reason: During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment o...
Z-1849-2022October 5, 2022deerfield, IL
Leica Microsystems, Inc.
Class IIOngoing
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Reason: During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment o...
Z-1850-2022October 5, 2022deerfield, IL
Leica Microsystems, Inc.
Class IIOngoing
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Reason: During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment o...
Z-1851-2022October 5, 2022deerfield, IL
Cardiac Assist, Inc
Class ITerminated
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Reason: Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
Z-1763-2022October 5, 2022Pittsburgh, PA
CareFusion 303, Inc.
Class IIOngoing
BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . MedBank 200 Main operating with Windows 7 . MedBank...
Reason: The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet system will sto...
Z-1785-2022October 5, 2022San Diego, CA
Mallinckrodt, LLC.
Class IIOngoing
INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of n...
Reason: The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein ...