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.

1026–1050 of 1335

HighFDA (Devices)·Z-1742-2015·2015-06-17
Ortho-Clinical VITROS 4600 Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System software versions 3.2 and below due to a defect that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.
Product
VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2015·2015-06-17
Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry System software due to a defect that allows improper sample metering for urine assays requiring acidification.
Product
VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1719-2015·2015-06-17
Elekta Recalls Leksell GammaPlan Software Due to Memory Corruption
Elekta is recalling 10 units of Leksell GammaPlan 10.2 software because memory can become corrupted when creating a fused study via drag and drop.
Product
Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1705-2015·2015-06-10
Siemens Medical Software Recall for Missing Image Measurements on Printouts
Siemens Medical Solutions is recalling 167 units of Syngo.via and Syngo.x software because measurements on subsequent images do not appear on printouts.
Product
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1675-2015·2015-06-03
Mindray Recalls Panorama Patient Monitoring Network Due to Software Anomaly
Mindray is recalling four Panorama Patient Monitoring Network units due to a software anomaly that prevents arrhythmia alarms from displaying on the Panorama system after a restart.
Product
Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients withi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1645-2015·2015-06-03
Siemens SOMATOM Emotion 16 CT Scanner Software Recall
Siemens is recalling 75 SOMATOM Emotion 16 CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.
Product
SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1644-2015·2015-06-03
Siemens SOMATOM Emotion 6 CT Scanner Software Recall
Siemens Medical Solutions is recalling 75 SOMATOM Emotion 6 CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.
Product
SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1668-2015·2015-06-03
Siemens Axiom Luminos dRF Max Recall for Software Data Loss
Siemens is recalling 133 Axiom Luminos dRF Max imaging systems due to a software defect that can cause acquired images to be deleted, requiring studies to be repeated.
Product
SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1646-2015·2015-06-03
Siemens SOMATOM Perspective CT Scanner Software Recall
Siemens is recalling 75 SOMATOM Perspective CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.
Product
SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1670-2015·2015-06-03
Siemens Uroskop Omnia Max X-Ray System Software Data Loss Recall
Siemens is recalling 133 Uroskop Omnia Max X-ray systems due to software defects that cause image deletion and connection issues.
Product
SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1669-2015·2015-06-03
Siemens Luminos Agile Max Imaging System Software Recall
Siemens is recalling 133 Luminos Agile Max imaging systems due to a software defect that causes image loss and connection issues.
Product
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1667-2015·2015-06-03
Siemens Ysio Max Radiographic System Recalled for Software Data Loss
Siemens is recalling 133 Ysio Max radiographic systems because a software defect can delete acquired images and studies, requiring patients to repeat exposures.
Product
SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It c
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1554-2015·2015-05-27
Philips DigitalDiagnost X-Ray System Recalled for Missing Exposure Beep Signal
Philips Medical Systems is recalling 54 DigitalDiagnost X-Ray systems because they fail to emit a beep signal after exposure if powered on for over 12 hours.
Product
Philips Healthcare DigitalDiagnost System X-Ray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1574-2015·2015-05-13
MHI-TM2000 Linear Accelerator System Software Recall for Communication Errors
Mitsubishi Heavy Industries is recalling 11 MHI-TM2000 Linear Accelerator Systems due to a software defect that allows radiation delivery despite communication errors and prevents saving treatment records.
Product
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1582-2015·2015-05-13
Brainlab ExacTrac 6.x Software Recalled for Potential Positioning Errors
Brainlab AG is recalling ExacTrac 6.x software due to potential patient positioning errors when using CBCT at non-zero couch angles.
Product
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1581-2015·2015-05-13
Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Capture Failures
Siemens is recalling 186 ACUSON SC2000 ultrasound systems because they may fail to capture images or clips during routine scans.
Product
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1587-2015·2015-05-13
Stryker Universal Battery Charger Recalled for Software Data Transmission Issue
Stryker is recalling 223 Universal Battery Chargers because they are not transmitting usage data to the Stryker Cloud as designed. A software correction is being initiated.
Product
Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1548-2015·2015-05-06
Dako Omnis Software Module Recalled for Test Request Errors
Dako North America is recalling the Test Request Distributor software module for the Dako Omnis System because it may execute the wrong test after a user updates a request.
Product
Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test reques
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1561-2015·2015-05-06
Steris Recalls AMSCO Steam Sterilizers Due to Software Defect
Steris is recalling 701 AMSCO C and AMSCO 400 steam sterilizers because a software defect may interrupt processing cycles, causing procedure delays.
Product
AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1451-2015·2015-04-22
Baxter SIGMA Spectrum Infusion Pump Software Recall for Dose Display Discrepancy
Baxter is recalling SIGMA Spectrum Infusion Pump software due to a discrepancy between Master Drug Library settings and pump display, which may cause therapy delays or unintended delivery rates.
Product
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administratio
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-1399-2015·2015-04-15
Siemens ADVIA Chemistry XPT Software Recall for Sample Processing Error
Siemens is recalling ADVIA Chemistry XPT software version 1.0.2 because samples may remain in an 'Inprocess' state, preventing test results from transmitting to the Laboratory Information System.
Product
ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1369-2015·2015-04-08
Roche Recalls Accu-Chek Connect App Due to Inaccurate Bolus Advice
Roche Diabetes Care is recalling the Accu-Chek Connect app because a screen orientation change may cause it to provide inaccurate bolus advice to users.
Product
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1359-2015·2015-04-08
Philips CT Systems Recalled for Inverted Scan Position Software Defect
Philips is recalling 424 CT systems worldwide because a software defect inverts the sign of the longitudinal position for some scans.
Product
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1354-2015·2015-04-08
Siemens Syngo.plaza PACS Recalled for Incomplete Archived Studies
Siemens Medical Solutions is recalling four Syngo.plaza PACS units because they may leave partially archived studies unarchived during pre-fetch operations.
Product
Syngo.plaza. 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.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0984-2015·2015-03-25
Siemens ARTISTE MV System Linear Accelerator Recalled for Software Issue
Siemens is recalling three ARTISTE MV System linear accelerators due to a software issue that may cause a dark current phenomenon during specific cancer treatments.
Product
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
Category
Medical Device
Distribution
3 states