The Recall Desk

Hazard

Software Defect recalls

1,375 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,375
Critical
14
Severe
106
Most recent
2026-10-21

Of the 1,375 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 106 (8%) 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.

726–750 of 1375

  • ModerateFDA (Devices)·Z-1611-2018·2018-05-09

    Roche OMNI S4 Analyzer Recalled for Software Scheduler Failure

    Roche Diagnostics is recalling 1,026 OMNI S4 analyzers because a software defect prevents the AutoQC scheduler from activating.

    Product
    Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1612-2018·2018-05-09

    Roche OMNI S6 Analyzer Software Defect Recalled by FDA

    Roche Diagnostics is recalling 1,026 OMNI S6 analyzers because a software defect prevents scheduled AutoQC measurements from starting.

    Product
    cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1589-2018·2018-05-09

    Philips Allura Xper and UNIZ Systems Recalled for Monitor Freezing

    Philips is recalling 682 Allura Xper and UNIZ interventional fluoroscopic x-ray systems because the large screen monitor may freeze for 15 seconds after continuous operation.

    Product
    Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging…
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1399-2018·2018-04-25

    Siemens Oncor Expression Linear Accelerator Software Update Recall

    Siemens is recalling two Oncor Expression linear accelerators to update software and reduce the risk of collision during automated cancer treatments.

    Product
    ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1396-2018·2018-04-25

    Philips Brilliance 64 CT Scanner Software Defect Recall

    Philips is recalling 291 Brilliance 64 CT scanners because a software defect prevents Surview scans from initializing when tube current is below 30 mA.

    Product
    Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1401-2018·2018-04-25

    Siemens Oncor Impression Plus Linear Accelerator Software Recall

    Siemens is recalling 15 Oncor Impression Plus linear accelerators to update software and reduce the risk of collision during automated cancer treatments.

    Product
    ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1365-2018·2018-04-18

    Fresenius Liberty Select Cycler Recalled for Software Overfill Risk

    Fresenius Medical Care is recalling Liberty Select Cyclers due to a software issue that may cause overfill, posing a risk of serious injury or death.

    Product
    Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2018·2018-04-11

    Fresenius K2 Hemodialysis Machines Recalled for SLED Program Software Defect

    Fresenius Medical Care is recalling 127 K2 Hemodialysis Machines because a software defect may allow the ultrafiltration pump to run at unsafe rates during SLED treatments.

    Product
    2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1276-2018·2018-04-11

    Phadia Prime software recall for EliA assay retesting function

    Phadia Ab is recalling Phadia Prime software versions up to 2.1.4 to prevent the use of the 'OK to All' function when rejecting and retesting EliA assay samples.

    Product
    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1261-2018·2018-04-04

    Siemens Syngo.via software recall due to data archiving configuration error

    Siemens is recalling 165 units of Syngo.via software because a software upgrade disabled a data cleanup function, causing incorrect archiving flags and reduced disk capacity.

    Product
    Syngo.via software is 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 based software options.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0943-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling three Proteus 235 proton therapy systems because the internal configuration of electrometers and control boards is not checked before each patient treatment.

    Product
    Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2018·2018-03-21

    Brainlab ExacTrac Software Recall for Beam Authorization Misinterpretation Risk

    Brainlab AG is recalling ExacTrac Patient Positioning System software versions 6.0 through 6.5 due to a risk of misinterpreting beam authorization when used with specific Varian accelerators.

    Product
    ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0846-2018·2018-03-14

    Mindray A-Series Anesthesia Delivery System Software Recall

    Mindray is recalling 2,875 A-Series anesthesia delivery systems due to a software issue that may apply incorrect settings or skip startup leak tests.

    Product
    A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0847-2018·2018-03-14

    Mindray A7 Anesthesia Delivery System Recalled for Software Defect

    Mindray is recalling A7 Anesthesia Delivery Systems because a software issue may cause incorrect settings to be applied or the startup leak test to be skipped.

    Product
    A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0928-2018·2018-03-14

    Medtronic O-arm 1000 X-ray System Software Update Recall

    Medtronic is recalling 253 O-arm 1000 mobile X-ray systems to implement a software update that resolves multiple operational and imaging defects.

    Product
    O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0926-2018·2018-03-14

    Abbott i-STAT DE Handheld Module Software Update Recall

    Abbott Point Of Care Inc. is recalling 894 i-STAT DE handheld data processing modules because a software upgrade resets customized settings and prevents certain data from updating.

    Product
    i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0812-2018·2018-03-07

    ZOLL 731 Series Ventilators Recalled for Software Anomaly

    ZOLL Medical Corporation is recalling 46 units of 731 Series Ventilators due to a software anomaly that may allow users to inadvertently change device settings.

    Product
    731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0829-2018·2018-03-07

    Fresenius 2008T Hemodialysis Systems Recalled for Software Anomaly

    Fresenius Medical Care is recalling 15 hemodialysis machines due to a software error that causes a discrepancy between the displayed and actual ultrafiltration rates.

    Product
    2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2018·2018-03-07

    Philips Intellivue iX Software Recall for Patient Discharge Failure

    Philips is recalling Intellivue iX Information Center Software because restarting stations in 2018 prevents patient discharge and transfer operations, causing monitoring loss.

    Product
    Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0772-2018·2018-03-07

    Steris V-PRO 60 Sterilizer Software Recall to Prevent Expired Sterilant Use

    Steris Corporation is recalling 406 V-PRO 60 Low Temperature Sterilization Systems to update software that prevents the use of expired sterilant.

    Product
    V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0808-2018·2018-03-07

    Siemens Syngo.via Software Recall for Diagnostic Inconsistencies

    Siemens Medical Solutions is recalling 30 Syngo.via systems with software version VB20A to resolve bugs and inconsistent diagnoses.

    Product
    Syngo.via systems with SW VB20A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0635-2018·2018-02-28

    Oculus Pentacam AXL Software Recall for Erroneous Quality Markings

    Oculus Optikgeraete GmbH is recalling 83 Pentacam AXL devices due to a software anomaly that may produce erroneous quality specification markings.

    Product
    OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0562-2018·2018-02-21

    Philips Ingenuity TF PET/CT Software Recall for Reconstruction Failures

    Philips is recalling 24 Ingenuity TF PET/CT systems due to a software defect that causes intermittent PET reconstruction failures, rendering acquired data unusable.

    Product
    Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0518-2018·2018-02-14

    Philips Brilliance 64 CT System Recalled for Software Issues

    Philips Medical Systems is recalling 1,801 Brilliance 64 CT systems due to software issues in version 4.1.6.

    Product
    Philips Brilliance 64 computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0519-2018·2018-02-14

    Philips Ingenuity Core CT System Software Recall

    Philips Medical Systems is recalling Ingenuity Core CT systems due to software issues in Brilliance iCT 4.1.6.

    Product
    Philips Ingenuity Core computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states