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.

Which agencies issued them

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.

1226–1250 of 1335

HighFDA (Devices)·Z-1402-2013·2013-06-05
Elekta Integrity 3.0 Multileaf Collimator Recalled for Beam Delivery Tolerance Issues
Elekta, Inc. is recalling Integrity 3.0 multileaf collimators because incorrect static tolerances may prevent the detection of unexpected movement during radiation beam delivery.
Product
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1419-2013·2013-06-05
RayStation Therapy Treatment Planning System Recalled for Image Offset Errors
RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System software versions 2.0, 2.5, and 3.0 because imported medical images may be offset by one pixel, potentially leading to incorrect dose calculations.
Product
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1375-2013·2013-06-05
Intel-GE QuietCare Recall Issued for Duplicate Alert Functionality
Intel-GE Care Innovations LLC is recalling QuietCare monitoring systems because customers reported receiving duplicate alerts. The recall affects 1,722 units distributed in the US and Great Britain.
Product
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1374-2013·2013-06-05
Intel-GE Care Innovations Recalls QuietCare-Networked Monitoring Devices
Intel-GE Care Innovations is recalling 46 QuietCare-Networked devices due to duplicate alerts. The devices are used to monitor senior housing residents.
Product
QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1345-2013·2013-05-29
Technidata TD-Synergy Laboratory Information System Software Recall
Technidata is recalling TD-Synergy Laboratory Information System software because a specific keyboard shortcut can modify previously entered test results.
Product
TD-Synergy. Laboratory Information System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1339-2013·2013-05-29
Boston Scientific Recalls LATITUDE Patient Management System Software
Boston Scientific is recalling the LATITUDE Patient Management System software because a system update caused clinic faxes to display illegible characters instead of required patient information.
Product
LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1182-2013·2013-05-08
Siemens Medical Solutions Recalls RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling RT Therapist software versions 4.2.108 to fix multiple safety-related issues on linear accelerator systems.
Product
Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1164-2013·2013-05-01
GE Healthcare Recalls Xeleris 2 Workstation Due to Software Artifact Risk
GE Healthcare is recalling 11 Xeleris 2 Processing & Review Workstations due to a software issue that may cause image artifacts in MPI studies, potentially leading to misdiagnosis.
Product
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imagin
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1163-2013·2013-05-01
Varian RPM Respiratory Gating System Recall for Waveform Anomaly
Varian is recalling RPM Respiratory Gating System v1.7.5 units because they may produce inverted respiratory waveforms during specific sessions.
Product
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1133-2013·2013-04-24
GE Healthcare Recalls Muse v7 Cardiology System Due to Medication Display Error
GE Healthcare is recalling Muse v7 cardiology systems because they may display incorrect medications, potentially leading to incorrect patient treatment.
Product
GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1112-2013·2013-04-24
Carefusion Recalls Alaris PC Unit 8015 Due to Bolus Programming Risk
Carefusion is recalling 4,090 Alaris PC unit model 8015 devices with software version 9.12 due to potential data loss risks during bolus programming.
Product
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1141-2013·2013-04-24
Horiba ABX PENTRA 400 I.S.E. Module Recalled for Missing Linearity Flags
Horiba Medical is recalling ABX PENTRA 400 I.S.E. Modules because the software lacks Linearity Limit Flags for I.S.E. assays, which may prevent users from detecting out-of-range values.
Product
HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1077-2013·2013-04-17
Siemens Medical Solutions Recalls Elekta MOSAIQ Software Due to Safety Risk
Siemens Medical Solutions is recalling Elekta MOSAIQ Oncology Information System software versions below 2.41 due to a potential safety risk identified by the manufacturer.
Product
ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1067-2013·2013-04-17
Toshiba Aquilion 32/64 CT Systems Recalled for Software Display Error
Toshiba American Medical Systems is recalling 23 Aquilion 32/64 CT scanners due to a software issue that may cause incorrect Dose Length Product values to display.
Product
TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1068-2013·2013-04-17
Toshiba CT System Recalled for Software Error in Low-Current Scans
Toshiba American Medical Systems Inc. is recalling one CT scanner in Maryland due to a software defect that may trigger false error messages during low-current scans.
Product
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1043-2013·2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for linear accelerators to address multiple performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended us
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1036-2013·2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1029-2013·2013-04-10
Philips Ingenuity TF PET/CT Software Update Addresses Potential Safety Risks
Philips is updating software on one Ingenuity TF PET/CT system in Ohio to fix issues that could cause inaccurate readings or pose risks to patients and staff.
Product
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1044-2013·2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and safety issues that were not considered critical for immediate correction.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended us
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1041-2013·2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.2, Part No. 10568431, Current R640; Product Usage: The intended use
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1040-2013·2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Performance Defects
Siemens is recalling COHERENCE RT Therapist software versions to address performance defects and safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.1, Part No. 8147667, Current R640; Product Usage: The intended use
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1042-2013·2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Performance Defects
Siemens is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i, Part No. 7341428, Current R610/R630; Product Usage: The intended us
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1039-2013·2013-04-10
Siemens COHERENCE RT Therapist Software Recalled for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.0, Part No. 8139839, Current R630; Product Usage: The intended us
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1037-2013·2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Safety Defects
Siemens is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH, Part No. 7339125, - Current R630; Product Usage: The intended use of
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1038-2013·2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions to address performance defects and non-critical safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE Impression TH, Part No. 7341410, Current R630; Product Usage: The intend
Category
Medical Device
Distribution
0 states