The Recall Desk

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.

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.

876–900 of 1375

  • ModerateFDA (Devices)·Z-2867-2016·2016-09-28

    Invivo Recalls Philips Expression IP5 MRI Patient Monitoring Units

    Invivo Corporation is recalling 639 Philips Expression Information Portal (IP5) units because display numerics may freeze and menu keys may disable after extended run time.

    Product
    Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2872-2016·2016-09-28

    McKesson Radiology Software Recalled for Missing STAT Priority Icon

    McKesson Medical Imaging Group is recalling McKesson Radiology software versions 12.1.1 and 12.2 because the STAT priority icon was not displayed in the Study List when a study was opened.

    Product
    McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital…
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2796-2016·2016-09-21

    Merge Healthcare Recalls RadSuite Software Due to Missing Studies

    Merge Healthcare is recalling RadSuite software versions where studies may be missing from archives before watermarking.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2736-2016·2016-09-14

    Philips BrightView XCT Gamma Camera Recalled for Software Defect

    Philips Medical Systems is recalling 424 BrightView XCT gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2016·2016-09-14

    Philips BrightView X Gamma Camera Recalled for Software Defect

    Philips Medical Systems is recalling 117 BrightView X gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2016·2016-09-07

    GE Healthcare Recalls Centricity Laboratory Software Due to Data Deletion Errors

    GE Healthcare is recalling Centricity Laboratory software versions 3.3 to 4.1 because deleting a slave panel incorrectly removes free-text notes and reference ranges from the master panel.

    Product
    Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2712-2016·2016-09-07

    Elekta Monaco RTP System Software Recall for Contour Deletion Error

    Elekta, Inc. is recalling the Monaco RTP System software due to a defect where deleted contours may remain in treatment plans.

    Product
    Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-2685-2016·2016-09-07

    Merge Healthcare Recalls RadSuite Software Due to Image Display Errors

    Merge Healthcare is recalling RadSuite software versions 8.30.6 through 8.30.6.3 because interventional radiology images are not displaying correctly.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2686-2016·2016-09-07

    Merge Healthcare Recalls iConnect Enterprise Archive Due to Image Display Issues

    Merge Healthcare is recalling iConnect Enterprise Archive software because interventional radiology images are not displaying correctly in RadSuite.

    Product
    iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2609-2016·2016-08-31

    Baxter HomeChoice Peritoneal Dialysis Systems Recalled for Software Defect

    Baxter is recalling HomeChoice and HomeChoice PRO automated peritoneal dialysis systems due to a software defect that may cause serious complications in patients with ascites.

    Product
    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2627-2016·2016-08-31

    Merge Healthcare Recalls RadSuite Software Due to Image Display Error

    Merge Healthcare is recalling RadSuite software versions 5.30 and 5.35 because the viewer may skip image slices when navigating with multiple viewports.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2658-2016·2016-08-31

    Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Defect

    Philips is recalling three Ingenuity Core128 CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.

    Product
    Ingenuity Core128, Model number 728323 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
  • HighFDA (Devices)·Z-2657-2016·2016-08-31

    Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Defect

    Philips is recalling 30 Ingenuity Core CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scans.

    Product
    Ingenuity Core, Model number 728321 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-2656-2016·2016-08-31

    Philips Brilliance CT 16 Power Software Defect Recall

    Philips is recalling 50 Brilliance CT 16 Power systems due to a software defect that may cause planned anatomy to be cut off in images, potentially requiring a rescan.

    Product
    Brilliance CT 16 Power, Model number 728240 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-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-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-2659-2016·2016-08-31

    Novarad NovaPACS Software Recalled for Prematurely Released Pop-up Screen

    Novarad Corporation is recalling NovaPACS software versions 8.4.7, 8.5.3, and 8.5.6 due to a prematurely released pop-up screen.

    Product
    NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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-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
  • 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-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-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