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.

851–875 of 1335

ModerateFDA (Devices)·Z-2653-2016·2016-08-31
Philips Brilliance CT Big Bore Oncology Software Recall
Philips is recalling 33 Brilliance CT Big Bore Oncology systems due to a software defect that may cause planned anatomy to be cut off in gated helical CT images.
Product
Brilliance CT Big Bore Oncology, Model number 728243 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2655-2016·2016-08-31
Philips Brilliance 16 CT Scanner Recalled for Image Reconstruction Defect
Philips Medical Systems is recalling 192 Brilliance 16 CT scanners because a software upgrade can cause planned anatomy to be cut off in images, potentially requiring a rescan.
Product
Brilliance 16, Model number 728246 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2652-2016·2016-08-31
Philips Brilliance 64 CT Scanner Recalled for Image Reconstruction Errors
Philips is recalling 283 Brilliance 64 CT scanners because a software update can cause planned anatomy to be cut off in images, potentially requiring a rescan.
Product
Brilliance 64 CT 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2579-2016·2016-08-24
GE Centricity PACS Workstation Recalled for Image Grouping Errors
GE Healthcare is recalling 498 Centricity PACS Workstations due to a software defect that causes random image-series grouping errors when specific exams are opened simultaneously.
Product
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2347-2016·2016-08-17
Philips MX 16-slice CT Systems Recalled for Software Defects
Philips is recalling 80 MX 16-slice CT systems due to software bugs that may cause image mix-ups or scan interruptions.
Product
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2385-2016·2016-08-17
Philips Ingenuity CT Software Recall for Performance Issues
Philips Medical Systems is recalling 205 Ingenuity CT units due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.
Product
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-2525-2016·2016-08-17
Siemens Stratus CS STAT Fluorometric Analyzer Software Defect Recall
Siemens is recalling Stratus CS STAT Fluorometric Analyzers due to a software defect that may cause inaccurate test results or out-of-range values when TestPaks are near expiration.
Product
Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2382-2016·2016-08-17
Philips Brilliance iCT SP CT Scanner Software Recall
Philips is recalling 57 Brilliance iCT SP CT scanners due to software issues in versions 4.1.3 and 4.1.5 that could affect equipment performance.
Product
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2367-2016·2016-08-17
Philips Brilliance BigBore CT Systems Recalled for Software Defect
Philips is recalling eight Brilliance BigBore Oncology CT systems due to a software defect causing intermittently slow response of the Host.
Product
Brilliance BigBore Oncology 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.
Category
Medical Device
Distribution
46 states
ModerateFDA (Devices)·Z-2383-2016·2016-08-17
Philips CT Scanner Software Recall for Performance Issues
Philips is recalling Ingenuity Core CT scanners due to software issues in versions v4.1.3, v4.1.4, and v4.1.5 that could affect equipment performance.
Product
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2369-2016·2016-08-17
Philips Brilliance 16 CT Systems Recalled for Software Defect
Philips Medical Systems is recalling 203 Brilliance 16 CT systems due to a software defect causing intermittently slow response of the Host.
Product
Brilliance 16 Computed Tomography X-ray systems is 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
46 states
ModerateFDA (Devices)·Z-2380-2016·2016-08-17
Philips Brilliance 64 CT Scanner Software Recall
Philips is recalling Brilliance 64 CT scanners due to software issues that could affect equipment performance.
Product
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2384-2016·2016-08-17
Philips Ingenuity CT Software Recall for Performance Issues
Philips is recalling Ingenuity Core128 CT scanners due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.
Product
Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2366-2016·2016-08-17
Philips Brilliance 64 CT Systems Recalled for Software Defect
Philips Medical Systems is recalling 318 Brilliance 64 Computed Tomography X-ray systems due to a software defect causing intermittently slow response of the Host.
Product
Brilliance 64 Computed Tomography X-ray systems is 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
46 states
ModerateFDA (Devices)·Z-2371-2016·2016-08-17
Philips Ingenuity Core CT Systems Recalled for Software Defect
Philips Medical Systems is recalling 29 Ingenuity Core CT systems due to a software defect causing intermittently slow response of the Host.
Product
Ingenuity Core Computed Tomography X-ray systems is 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
46 states
ModerateFDA (Devices)·Z-2372-2016·2016-08-17
Philips Ingenuity Core 128 CT Systems Recalled for Software Defect
Philips is recalling five Ingenuity Core 128 CT systems due to a software defect causing intermittently slow response of the Host.
Product
Ingenuity Core 128 Computed Tomography X-ray systems is 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
46 states
ModerateFDA (Devices)·Z-2368-2016·2016-08-17
Philips Brilliance BigBore CT Systems Recalled for Software Defect
Philips Medical Systems is recalling 17 Brilliance BigBore CT systems due to a software defect causing intermittently slow response of the Host.
Product
Brilliance BigBore Radiology 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.
Category
Medical Device
Distribution
46 states
ModerateFDA (Devices)·Z-2381-2016·2016-08-17
Philips Brilliance iCT Recalled for Software Performance Issues
Philips Medical Systems is recalling 335 Brilliance iCT units due to software issues in versions v4.1.3 and v4.1.5 that could affect equipment performance.
Product
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2346-2016·2016-08-17
Philips MX 16-slice CT System Software Recall for Data Integrity Issues
Philips is recalling 899 MX 16-slice CT systems due to software defects that may cause patient image mix-ups or scan interruptions.
Product
MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-2370-2016·2016-08-17
Philips Brilliance CT 16 Power Systems Recalled for Software Defect
Philips Medical Systems is recalling 55 Brilliance CT 16 Power systems due to a software defect causing intermittently slow response of the Host.
Product
Brilliance CT 16 Power Computed Tomography X-ray systems is 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
46 states
HighFDA (Devices)·Z-2341-2016·2016-08-10
Merge HEMO software recall for inaccurate INR display
Merge Healthcare is recalling 37 units of Merge HEMO software because the displayed International Normalized Ratio (INR) value does not match the imported value.
Product
Merge HEMO software.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2303-2016·2016-08-10
Merge PACS Software Recall for Annotation Display Defect
Merge Healthcare is recalling Merge PACS 6.0 software because it fails to display annotations on certain loaded studies.
Product
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2318-2016·2016-08-10
Medtronic Navigation Recalls StealthStation Software Applications
Medtronic Navigation is voluntarily recalling StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Product
MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2313-2016·2016-08-10
Medtronic Navigation Recalls Synergy Cranial S7 Software Applications
Medtronic Navigation is conducting a voluntary field action for Synergy Cranial S7 software applications due to compatibility issues with specific floor-based scanners.
Product
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2315-2016·2016-08-10
Medtronic Navigation Recalls S7 MACH FrameLink Software Applications
Medtronic Navigation is conducting a voluntary field action for S7 MACH FrameLink software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Product
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous pr
Category
Medical Device
Distribution
Distributed nationwide