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.

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.

776–800 of 1375

ModerateFDA (Devices)·Z-0094-2018·2017-11-22
Siemens Symbia Intevo 6 SPECT/CT Software Recall for Data Input Error
Siemens is recalling two Symbia Intevo 6 SPECT/CT systems because a software option may prevent users from modifying specific data input values during calibration.
Product
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0093-2018·2017-11-22
Siemens Symbia Intevo 16 SPECT/CT Software Recall for Data Input Error
Siemens is recalling two Symbia Intevo 16 SPECT/CT systems because a software option may prevent users from modifying specific data input values.
Product
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0049-2018·2017-11-01
FDA Requests Removal of Ablatherm Ultrasound System Software Settings
FDA requested the removal of specific energy treatment settings from 12 Ablatherm ultrasound systems in the U.S. pending clinical data evaluation.
Product
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0050-2018·2017-11-01
Nucletron Oncentra Brachy 4.5 Software Recalled for Incorrect Source Step Size
Nucletron BV is recalling Oncentra Brachy 4.5 radiation therapy software because incorrect source step sizes may occur in treatment plans.
Product
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0020-2018·2017-10-25
Philips Brilliance iCT SP CT Systems Recalled for Image Reconstruction Failure
Philips is recalling Brilliance iCT SP CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.
Product
Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0015-2018·2017-10-25
Philips Brilliance 64 CT Systems Recalled for Image Reconstruction Failure
Philips Electronics North America Corporation is recalling 606 Brilliance 64 CT systems in the US because a software defect prevents image reconstruction after certain scans.
Product
Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0016-2018·2017-10-25
Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Failure
Philips is recalling 606 Ingenuity Core CT systems in the US because a software defect prevents image reconstruction after bolus tracking scans.
Product
Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0019-2018·2017-10-25
Philips Brilliance iCT CT Scanner Recall for Data Reconstruction Failure
Philips is recalling Brilliance iCT CT scanners because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.
Product
Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0018-2018·2017-10-25
Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Failure
Philips is recalling Ingenuity Core128 CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patient rescans.
Product
Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0017-2018·2017-10-25
Philips Ingenuity CT Systems Recalled for Bolus Tracking Image Failure
Philips is recalling Ingenuity CT systems because a software defect prevents image generation during bolus tracking procedures, potentially requiring patient rescans.
Product
Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3130-2017·2017-09-20
Mako Surgical Recalls Robotic Knee System Due to Software Display Error
Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.
Product
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3110-2017·2017-09-13
Elekta MOSAIQ Radiation Therapy System Recalled for Vertical Table Shift Error
Elekta is recalling the MOSAIQ Medical Charged-Particle Radiation Therapy System because a software error inverts vertical table shifts, potentially directing therapy to incorrect areas.
Product
MOSAIQ Medical Charged-Particle Radiation Therapy System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3113-2017·2017-09-13
Beckman Coulter Hematology Analyzers Recalled for Potential Blast Detection Failure
Beckman Coulter is recalling LH 750, LH 780, and LH 500 analyzers because they may fail to flag blasts in some blood samples.
Product
Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3105-2017·2017-09-13
Merge Unity Software Recall for Incorrect Gail Risk Calculations
Merge Healthcare is recalling Merge Unity software versions 10.0 through 11.1.2 Patch 4 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations.
Product
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3045-2017·2017-09-06
Neusoft NeuViz 128 CT Scanner Software Defect Recall
Neusoft Medical Systems is recalling 154 NeuViz 128 CT scanners due to a software defect. The FDA mandated this Class II recall for units distributed nationwide.
Product
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3075-2017·2017-09-06
BioMérieux Recalls VITEK 2 Compact 15 Software and Reagent Cards
BioMérieux is recalling VITEK 2 Compact 15 software and reagent cards because they may fail to finalize test results after a software update.
Product
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-3044-2017·2017-09-06
Neusoft Medical NeuViz 64 CT Scanner Software Defect Recall
Neusoft Medical Systems is recalling 234 NeuViz 64 CT scanners due to a software defect. The FDA mandated this recall for units distributed nationwide.
Product
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·17V485000·2017-08-02
2017 Jeep Renegade Recall for Instrument Panel Software Defect
Chrysler is recalling 2017 Jeep Renegade vehicles because a software issue may cause malfunction indicator lamps to illuminate incorrectly, potentially masking true vehicle faults.
Product
JEEP — JEEP RENEGADE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2735-2017·2017-07-26
Agfa Healthcare Recalls NX 3.0.8950 Imaging Processing Software
Agfa Healthcare is recalling NX 3.0.8950 software because it may temporarily display and transmit incorrect patient images to PACS systems.
Product
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-2732-2017·2017-07-19
Nova Biomedical Stat Profile Prime Analyzer Software Recall
Nova Biomedical is recalling Stat Profile Prime Analyzers because a software defect could cause scheduled quality control tests to overwrite pending patient results.
Product
Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2684-2017·2017-07-12
Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems Due to Software Issue
Ion Beam Applications S.A. is voluntarily recalling six Proteus 235 Proton Therapy Systems worldwide due to a software issue. Five of these units are located in the United States.
Product
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2628-2017·2017-07-05
Merge Healthcare Recalls LIS Software Due to Potential Wrong Results Verification
Merge Healthcare is recalling specific versions of its LIS software because wrong laboratory results could be inadvertently verified under certain conditions.
Product
Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2633-2017·2017-07-05
Elekta MOSAIQ Oncology System Recalled for Care Plan Update Failure
Elekta is recalling MOSAIQ Oncology Information System versions 2.50.05 and higher because outdated information may remain in order sets, potentially affecting treatment workflows.
Product
MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2601-2017·2017-06-28
Merge OrthoPACS software recalled due to data propagation failures
Merge Healthcare is recalling specific versions of Merge OrthoPACS software because studies may fail to transfer or import correctly between servers.
Product
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2620-2017·2017-06-28
Merge OrthoPACS Software Recalled for Annotation Display Error
Merge Healthcare is recalling Merge OrthoPACS software versions 6.6, 6.6.1, and 6.6.2 because prior studies may fail to display annotations.
Product
Merge OrthoPACS software.
Category
Medical Device
Distribution
Distributed nationwide