St Jude Medical, Cardiac Rhythm Management Division
Class IITerminated
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Manag...
Reason: Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Z-0808-2020January 22, 2020Sylmar, CA
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for t...
Reason: Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalcul...
Z-0736-2020January 1, 2020Stockholm
Carl Zeiss Meditec, Inc.
Class IITerminated
VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-...
Reason: VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software...
Z-0680-2020December 25, 2019Dublin, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
Reason: In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could resul...
Z-0695-2020December 25, 2019Malvern, PA
Polymer Technology Systems
Class IITerminated
Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
Reason: A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Reason: A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Z-0683-2020December 25, 2019Whitestown, IN
Polymer Technology Systems
Class IITerminated
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
Reason: A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Z-0686-2020December 25, 2019Whitestown, IN
Polymer Technology Systems
Class IITerminated
ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Reason: A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Z-0685-2020December 25, 2019Whitestown, IN
Polymer Technology Systems
Class IITerminated
A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058
Reason: A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Z-0682-2020December 25, 2019Whitestown, IN
Viewray, Inc.
Class IITerminated
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Reason: Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or wi...
Z-0676-2020December 18, 2019Mountain View, CA
Roche Diagnostics Operations, Inc.
Class IITerminated
Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
Reason: Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).
Z-0669-2020December 18, 2019Indianapolis, IN
LivaNova USA Inc
Class IIOngoing
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Reason: This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the sel...
Z-0663-2020December 18, 2019Houston, TX
Volcano Corporation
Class IITerminated
Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s...
Reason: Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
Reason: GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a lim...
Reason: GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a lim...
Z-0584-2020December 4, 2019Ballerup
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Reason: SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Seq...
Z-0265-2020November 27, 2019Malvern, PA
Neocis Inc.
Class IITerminated
Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and th...
Reason: The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Z-0511-2020November 27, 2019Miami, FL
Draegar Medical Systems, Inc.
Class IIOngoing
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Reason: The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.
Z-0372-2020November 20, 2019Andover, MA
Siemens Medical Solutions USA, Inc
Class IITerminated
Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #105900...
Reason: Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
Z-0406-2020November 20, 2019Malvern, PA
Baxter Healthcare Corporation
Class IIOngoing
Prismaflex Control Unit, software versions below 7.21
Reason: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Z-0277-2020November 13, 2019Deerfield, IL
Baxter Healthcare Corporation
Class IIOngoing
Prismaflex Control Unit, software versions below 7.21
Reason: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Z-0278-2020November 13, 2019Deerfield, IL
LivaNova USA Inc
Class IIOngoing
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. Th...
Reason: Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VN...
Z-0346-2020November 13, 2019Houston, TX
Baxter Healthcare Corporation
Class IIOngoing
Prismaflex Control Unit, software versions below 7.21
Reason: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Z-0276-2020November 13, 2019Deerfield, IL
Baxter Healthcare Corporation
Class IIOngoing
Prismaflex Control Unit, software versions below 7.21
Reason: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Z-0280-2020November 13, 2019Deerfield, IL
Baxter Healthcare Corporation
Class IIOngoing
Prismaflex Control Unit, software versions below 7.21
Reason: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.