The Recall Desk

Hazard

Software Defect recalls

1,335 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,335
Critical
14
Severe
91
Most recent
2026-09-09

Of the 1,335 software defect recalls we have scored against our rubric, 14 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 91 (7%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

776–800 of 1335

  • HighFDA (Devices)·Z-1780-2017·2017-04-19

    GE Healthcare Recalls Vivid Ultrasound Systems Due to Patient Selection Error

    GE Healthcare is recalling Vivid Ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.

    Product
    Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1768-2017·2017-04-19

    Nihon Kohden Bedside Monitor Recall for Pause Function Defect

    Nihon Kohden America Inc is recalling 654 bedside monitors because the pause function on central monitors fails to automatically resume when connected to specific Life Scope G9 units.

    Product
    Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1782-2017·2017-04-19

    GE Healthcare Recalls Centricity PACS Web Diagnostic Software

    GE Healthcare is recalling 118 units of Centricity PACS Web Diagnostic software due to a defect where study category labels and hanging positions appear incorrectly swapped.

    Product
    Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2017·2017-04-05

    Philips V60 Ventilator Recall for False Blower Motor Stall Detection

    Respironics is recalling 2,512 Philips V60 Ventilators with Version 2.20 software because they may falsely detect a blower motor stall, causing the device to shut down and cease ventilatory support.

    Product
    Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1682-2017·2017-04-05

    Hospira Plum 360 Infusion Pump Software Recall for Battery Alarm Defect

    Hospira is recalling 62,847 Plum 360 Infusion Pumps with software version 15.02 due to a defect that causes therapy to stop and incorrect alarms to display.

    Product
    Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2017·2017-04-05

    Siemens Syngo.x PACS Software Recalled for Addressing Multiple Issues

    Siemens Medical Solutions is recalling 104 Syngo.x PACS systems to install software updates that address several unspecified issues.

    Product
    Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo base
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2017·2017-04-05

    Siemens Syngo.via Software Recall for Medical Image System Issues

    Siemens Medical Solutions is recalling 104 units of Syngo.via picture archiving software to address several identified issues.

    Product
    Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo ba
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1494-2017·2017-03-29

    Nidek EC-5000 Excimer Laser Software Recall for Unintended Correction Programming

    Nidek Inc is recalling Final Fit Software versions 1.11 and 1.12 for the EC-5000 Excimer Laser System because treatment planning could be programmed with an unintended correction.

    Product
    Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1488-2017·2017-03-29

    Siemens Recalls 80 ARTISTE MV Systems for Software Update

    Siemens Medical Solutions is voluntarily recalling 80 ARTISTE MV Systems to install a software update. The devices were distributed throughout the United States.

    Product
    ARTISTE" MV System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1486-2017·2017-03-29

    Merge Healthcare Recalls Cardio Software Due to STAT Study Display Issue

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because the study list fails to display STAT studies without a manual refresh.

    Product
    Merge Cardio software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1491-2017·2017-03-29

    Siemens Recalls 80 ONCOR MRI Systems for Software Update

    Siemens Medical Solutions is voluntarily recalling 80 ONCOR MRI systems nationwide to install a software update.

    Product
    ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1415-2017·2017-03-29

    Merge Cardio Software Recall Due to Missing Read-Only Notification

    Merge Healthcare is recalling Merge Cardio software versions 9.0.9 and earlier because a defect allows two physicians to access the same study report without a read-only prompt.

    Product
    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1537-2017·2017-03-29

    Siemens ADVIA Centaur XPT Software Recall for Workflow Issues

    Siemens is recalling ADVIA Centaur XPT software versions V1.0.1 through V1.2 due to issues that may delay testing and affect system workflow.

    Product
    ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagent
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1533-2017·2017-03-29

    Siemens Syngo.plaza PACS Systems Recalled for Software Update Issues

    Siemens Medical Solutions is recalling 13 Syngo.plaza PACS systems nationwide due to software update issues. The recall is voluntary and has been terminated.

    Product
    Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1431-2017·2017-03-15

    Merge PACS Software Recalled for Telmed Protocol Data Propagation Failures

    Merge Healthcare is recalling specific versions of Merge PACS software because studies may fail to propagate or import via the telmed protocol.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2017·2017-03-08

    Merge Healthcare Recalls Unity PACS Software Due to Image Error

    Merge Healthcare is recalling Unity PACS software versions 11.0 and 11.0.1 because the software fails to add the correct tomo image.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2017·2017-03-08

    McKesson Radiology PACS Software Recall for Potential Missing Images

    McKesson Medical Imaging is recalling McKesson Radiology 12.2 PACS software due to a defect that may cause missing images or stuck imports.

    Product
    McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Devices)·Z-0788-2017·2017-03-08

    Medtronic SynchroMed II Software Card Recall for Priming Bolus Function

    Medtronic is recalling 22,298 SynchroMed II software application cards to update the priming bolus function and pump labeling.

    Product
    Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V132000·2017-03-02

    Subaru Recalls 2017 Impreza for Rearview Camera Software Issue

    Subaru is recalling 2017 Impreza vehicles because a software problem may cause the rearview camera display to malfunction, increasing crash risk.

    Product
    SUBARU — SUBARU IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2017·2017-03-01

    Merge Eye Station Import Utility Recalled for Image Import Errors

    Merge Healthcare is recalling the Eye Station Import Utility because images were not importing properly and were imported under "unknown" due to a validation issue.

    Product
    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1204-2017·2017-02-22

    Siemens CentraLink Software Recalled for Potential Sample Type Omission

    Siemens is recalling CentraLink Data Management System software versions v13x, v14x, and v15x because the system may download orders to the ADVIA Automation System without specifying the sample type.

    Product
    CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1200-2017·2017-02-22

    BioMerieux Recalls VIDAS 3 Software Version 1.1.4 Due to Anomalies

    BioMerieux SA is recalling 1,161 units of VIDAS 3 software version 1.1.4 in the U.S. because anomalies identified during the development of version 1.2 were found to be present in the current field version.

    Product
    VIDAS 3 software v. 1.1.4
    Category
    Medical Device
    Distribution
    0 states