The Recall Desk

Hazard

Imaging Defect recalls

13 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2024-12-11

Of the 13 imaging defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 imaging 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.

1–13 of 13

  • HighFDA (Devices)·Z-0606-2025·2024-12-11

    CT imaging system issue causes progressive image rotation during scans

    GE Healthcare CT systems have a technical issue causing progressive image rotation during helical and cardiac scans. No injuries reported, but unnoticed rotation could affect diagnosis or require rescans.

    Product
    GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1154-2024·2024-02-28

    X-Ray C-Arm System Internal Board Defect Causes Abnormal Images

    Canon Medical System X-ray C-arm systems may display abnormal images due to an internal board manufacturing defect, potentially preventing exam completion and requiring patients to be re-examined with alternative equipment.

    Product
    The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and proce
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1317-2023·2023-04-05

    Shoulder Glenoid Prosthesis Implant Manufactured Without Tantalum Markers

    A shoulder glenoid prosthesis implant (SMR TT Hybrid Std - Peg S) was manufactured without tantalum markers that aid in radiographic visualization. While alternative assessment methods using joint space, peg position, and cement observation remain available, the missing markers limit direct imaging capabilities.

    Product
    SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0133-2022·2021-10-27

    MRI System Software Defect May Cause Missing Anatomical Image Data

    GE Healthcare's SIGNA Architect MRI system may fail to generate complete image slices under certain software conditions, resulting in gaps within 3D volume images that could affect diagnostic imaging integrity.

    Product
    SIGNA Architect nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0139-2022·2021-10-27

    GE SIGNA Artist MRI System May Produce Incomplete Image Scans

    GE Healthcare recalls 18 SIGNA Artist MRI systems with a software defect that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.

    Product
    SIGNA Artist nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0132-2022·2021-10-27

    MRI System Software Defect Causes Missing Image Slices

    GE Healthcare is recalling 11 SIGNA Premier MRI systems. Under certain conditions, software versions RX29.1 and RX27.3 can cause missing slices in 3D imaging, creating gaps in anatomical data clinicians use for diagnosis.

    Product
    SIGNA Premier nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0137-2022·2021-10-27

    GE SIGNA MRI Systems Software Issue Causes Missing Image Slices

    GE Healthcare's SIGNA Creator and SIGNA Explorer MRI systems may produce incomplete 3D images due to missing slices in software version DV29.1. Missing anatomical information could impact diagnostic accuracy.

    Product
    SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0140-2022·2021-10-27

    MRI system software may produce incomplete 3D images

    GE Healthcare is recalling Optima MR450w 1.5T MRI systems due to a software issue in version DV29.1 that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.

    Product
    Optima MR450w 1.5T nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0141-2022·2021-10-27

    MRI System Recall: GE Healthcare SIGNA HDxt Missing Image Slices

    GE Healthcare is recalling the 1.5T SIGNA HDxt MR System due to a software issue that may cause missing slices in 3D volume images. Three devices distributed across the United States and internationally are affected.

    Product
    1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0783-2021·2021-01-13

    Medline Cardiac Pack Recall for Non-X-Ray Detectable Sponge Component

    Medline Industries is recalling Cardiac Pack - LF kits because the cylindrical sponge component is not x-ray detectable. The affected units were distributed only in Canada.

    Product
    Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3073-2017·2017-09-06

    Kentec Medical Recalls Pediatric Nasogastric Feeding Tubes Due to Radiopaque Stripe Defect

    Kentec Medical Inc is recalling specific lots of polyurethane ENFit nasogastric feeding tubes for pediatric and neonatal use because the radiopaque stripes are inadequately detectable.

    Product
    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQ
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-3074-2017·2017-09-06

    Kentec Medical Recalls Pediatric Nasogastric Feeding Tubes Due to Radiopaque Stripe Issue

    Kentec Medical Inc is recalling specific lots of Polyurethane ENFit Ameritus NG Feeding Tubes because the radiopaque stripes may be inadequately detectable.

    Product
    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY,
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1210-2015·2015-03-11

    Xoran MiniCAT X-ray devices recalled for imaging and dose defects

    Xoran Technologies is recalling 432 MiniCAT X-ray imaging devices nationwide due to out-of-tolerance kVp, unexposed frames, and out-of-tolerance dose.

    Product
    Xoran MiniCAT X-ray imaging device
    Category
    Medical Device
    Distribution
    Distributed nationwide