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.

676–700 of 1335

  • ModerateFDA (Devices)·Z-1940-2018·2018-06-06

    Siemens SOMATOM Go.Up CT Scanner Recalled for Software Issue

    Siemens is recalling 33 SOMATOM Go.Up CT scanners in the US due to a potential software issue that may require patient rescans.

    Product
    SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1745-2018·2018-05-23

    Siemens CT Scanners Recalled for Potential Unnecessary Radiation Exposure

    Siemens Medical Solutions is recalling 1,385 SOMATOM Definition AS CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure.

    Product
    SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighNHTSA·18V337000·2018-05-23

    Land Rover Recalls 2017 Models for Fuel Gauge Software Error

    Jaguar Land Rover is recalling 2017 Range Rover, Range Rover Sport, and Discovery vehicles because a software error may cause the engine to shut off unexpectedly.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT, DISCOVERY, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2018·2018-05-23

    Siemens Recalls CT Scanner Software for Radiation Risk

    Siemens Medical Solutions is recalling 134 SOMATOM Definition Edge CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1700-2018·2018-05-16

    Siemens Syngo.plaza Software Recalled to Prevent Patient Misdiagnosis

    Siemens Medical Solutions is recalling 92 units of Syngo.plaza software to fix date formatting and annotation issues that could lead to patient misdiagnosis.

    Product
    Syngo.plaza software 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 diagnosis and treatment planning. Syngo.plaza
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1778-2018·2018-05-16

    Siemens Syngo.Via Software Recall for Report Functionality Defect

    Siemens Medical Solutions is recalling Syngo.Via VB20A software because corrected report values are not saved or transmitted, causing the system to use original values.

    Product
    Syngo.Via VB20A model 1049610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2018·2018-05-09

    Siemens Atellica IM 1600 Analyzer Recalled for Reporting Factor Errors

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer systems because reporting and conversion factors may not apply to all connected analyzers.

    Product
    Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1446-2018·2018-05-09

    Siemens SOMATOM Emotion 16 CT Scanner Recalled for Dose Calculation Error

    Siemens Medical Solutions is recalling 1,301 SOMATOM Emotion 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.

    Product
    SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • 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 applica
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-1610-2018·2018-05-09

    Roche Omni S2 Analyzer Recall Due to Software Failure

    Roche Diagnostics is recalling 1,026 Omni S2 analyzers because a software defect prevents scheduled quality control measurements from starting.

    Product
    cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 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, hematocrit,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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, hematocrit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1613-2018·2018-05-09

    Roche cobas b 221 AutoQC Module Recall for Software Failure

    Roche Diagnostics is recalling cobas b 221 AutoQC Modules because a software defect prevents the scheduled quality control measurements from starting.

    Product
    cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 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, hematocrit,
    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, hematocrit,
    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
  • 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 device
    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 condit
    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 bod
    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