The Recall Desk

Hazard

Software Malfunction recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software malfunction 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.

1–25 of 109

  • HighFDA (Devices)·Z-2201-2026·2026-05-20

    Medtronic SynchroMed Flex Infusion Programmer Software Application

    Medtronic SynchroMed Flex Infusion Mode A810 Clinician Programmer Software may display infusion steps out of order, preventing medication from being delivered at the intended time. Affected devices are clinician programmer tablets worldwide.

    Product
    Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1937-2026·2026-04-29

    Protocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR

    Foundation Medicine is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx due to potential spontaneous closures of Hamilton HxRunControl software during protocol execution.

    Product
    Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2020-2025·2025-07-09

    Siemens Interventional Fluoroscopic X-Ray System Software Communication Failure

    Siemens interventional fluoroscopic x-ray systems may fail to communicate dose information between sensor and software, causing incorrect high-dose reporting. The manufacturer is recalling affected units worldwide.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2071-2025·2025-07-09

    Change Healthcare Cardiology Hemo Software Unexpected Shutdown Risk

    Change Healthcare is recalling Cardiology Hemo Software (version 14.3.2 and 15.0.1) because a software update may cause the system to unexpectedly shut down. The recall affects 29 systems distributed across multiple US states and international locations.

    Product
    Change Healthcare Cardiology Hemo Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1969-2025·2025-06-18

    Azurion R1.x and R2.x X-ray systems software communication issue

    Philips Medical Systems has recalled Azurion R1.x and R2.x X-ray systems worldwide due to a software issue that can cause loss of imaging functionality and delay treatment, potentially resulting in serious harm or death in patients undergoing urgent or complex interventions.

    Product
    Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: Al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1858-2025·2025-06-04

    Catalyst+ Patient Positioning Software May Fail to Apply Rotation Correctly

    C-RAD POSITIONING AB has recalled Catalyst+ and related patient positioning devices due to a software issue where field rotation may not be applied correctly during scanning.

    Product
    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Cataly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1798-2025·2025-05-28

    Ingenia Ambition S MRI devices recalled for alignment errors

    Philips is recalling certain Ingenia Ambition S MRI devices due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.

    Product
    Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1793-2025·2025-05-28

    Evolution Upgrade 1.5T imaging system alignment error recall

    Philips Evolution Upgrade 1.5T medical imaging systems may display alignment errors in cross-reference line functionality when reviewing images via MobiView application.

    Product
    Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1788-2025·2025-05-28

    Philips SmartPath to dStream 1.5T medical device alignment recall

    Philips is recalling certain SmartPath to dStream 1.5T medical imaging devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2025·2025-04-16

    Stryker Blueprint Mixed Reality Instrument Check Block Recall

    Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Instrument Check Block (Catalog Number MRUE203) due to an elevated complaint rate involving software and instrumentation malfunctions that prevent the system from functioning as intended.

    Product
    stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1541-2025·2025-04-16

    Stryker Blueprint Mixed Reality Instrument Kit Recall for Total Shoulder Arthroplasty

    Stryker is recalling the Blueprint Mixed Reality Instrument Kit for Total Shoulder Arthroplasty due to an elevated rate of complaints about software and instrumentation malfunctions that prevent the system from meeting its intended use.

    Product
    stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1540-2025·2025-04-16

    Stryker Blueprint Mixed Reality Depth Stop Pin Total Shoulder Arthroplasty Recalled

    Stryker is recalling the Blueprint Mixed Reality Depth Stop Pin (Catalog Number MRUE206) due to elevated complaints of software and instrumentation malfunctions that prevent intended use. The recall affects 474 units distributed in multiple US states and internationally.

    Product
    stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1535-2025·2025-04-16

    Stryker Blueprint Mixed Reality Glenoid Digitizer Software Functioning Issues

    Stryker is recalling the Blueprint Mixed Reality Glenoid Digitizer due to elevated complaint rates affecting system functionality. The device cannot reliably meet its intended use in total shoulder arthroplasty procedures.

    Product
    stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1536-2025·2025-04-16

    Stryker Blueprint Mixed Reality Coracoid Clamp Software and Instrumentation Issues

    Stryker is recalling the Blueprint Mixed Reality Coracoid Clamp due to elevated complaints about impaired software and instrumentation functioning that prevent the system from meeting its intended use in shoulder surgery guidance.

    Product
    stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1538-2025·2025-04-16

    Stryker Blueprint Mixed Reality surgical guidance system Class II recall

    Stryker is recalling the Blueprint Mixed Reality Box Base used in Total Shoulder Arthroplasty due to elevated complaints of software and instrumentation malfunctions that prevent intended use.

    Product
    stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1542-2025·2025-04-16

    Stryker HoloBlueprint Application Medical Device Software Functionality Recall

    Stryker is recalling the HoloBlueprint Application (Catalog Number MRUE001) for Total Shoulder Arthroplasty due to software and instrumentation malfunctions that prevent the system from meeting its intended use.

    Product
    stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1416-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid medical device software defect in emergency mode

    Baxter is recalling 2 units of TruSystem 7500 Hybrid (MC) due to a software issue that disables the upper back section adjustment when emergency mode is activated.

    Product
    Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2025·2025-04-02

    Baxter surgical table software issue blocks emergency back adjustment

    Baxter is recalling 112 units of the TruSystem 7500 surgical table due to a software issue preventing upper back adjustment during emergency mode. No injuries have been reported.

    Product
    Baxter Floor mounting column TruSystem 7500, Product Code 1717021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1422-2025·2025-04-02

    Software Malfunction Disables Back Control on Baxter TruSystem 7500

    Baxter TruSystem 7500 medical devices are affected by a software issue that prevents the upper back section from operating when emergency mode is enabled. Approximately 1,709 units have been recalled nationwide.

    Product
    Baxter TruSystem 7500, Product Code 4091000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1418-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid: Software Issue Disables Back Adjustment

    Baxter is recalling the TruSystem 7500 Hybrid due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.

    Product
    Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid IMRIS Upper Back Adjustment Software Malfunction

    A software issue in the Baxter TruSystem 7500 Hybrid MR IMRIS system prevents the upper back section from being adjusted when emergency mode is enabled. The recall affects 24 units distributed nationwide.

    Product
    Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1414-2025·2025-04-02

    Baxter TruSystem 7500 U Medical Device Software Malfunction Recall

    Baxter is recalling the Stationary column TruSystem 7500 U due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.

    Product
    Baxter Stationary column TruSystem 7500 U, Product Code 1730731
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1304-2025·2025-03-19

    BD Alaris Systems Manager Infusion Software Affected by Programming Request Issue

    BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units. The FDA has classified this as a Class I recall.

    Product
    BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1324-2025·2025-03-19

    Philips Spectral CT on Rails software recall due to scanning and movement issues

    Philips is recalling one unit of Spectral CT on Rails software version 5.1.0 due to multiple software problems causing scanning issues, image errors, and unintended device movement.

    Product
    Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
    Category
    Medical Device
    Distribution
    1 state
Software Malfunction recalls · The Recall Desk