The Recall Desk

Hazard

Imaging Artifact recalls

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

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2026-04-22

Of the 7 imaging artifact 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 artifact 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.

1–7 of 7

  • HighFDA (Devices)·Z-1823-2026·2026-04-22

    Gentuity HF-OCT imaging systems may repeat frames during catheter pullback

    Gentuity is issuing a correction for HF-OCT Imaging Systems because frames may repeat during pullback with Vis-Rx catheters, affecting longitudinal length measurements.

    Product
    Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0602-2025·2024-12-11

    CT Image Rotation Issue in GE Healthcare Optima 680 Systems

    GE Healthcare Optima 680 Expert CT systems may produce progressively rotated images during helical and cardiac scans. Affected images may require rescanning for accurate clinical interpretation.

    Product
    GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2648-2023·2023-10-11

    Siemens MAGNETOM headphones may create artifacts during MRI imaging

    Siemens Medical Solutions is recalling over-ear headphones used with MAGNETOM MRI systems. Lubricating grease in the headband may cause visible imaging artifacts during head examinations.

    Product
    (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max 1140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2830-2018·2018-08-22

    Beekley O-SPOT REF 791 Mammography Markers Recalled for Imaging Artifacts

    Beekley Corporation is recalling O-SPOT REF 791 and 791S skin markers because they may create imaging artifacts that mimic calcifications on mammograms.

    Product
    O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2018·2018-08-22

    Beekley TomoSPOT Mammography Skin Markers Recalled for Imaging Artifacts

    Beekley Corporation is recalling TomoSPOT skin markers used in mammography because they may create imaging artifacts that mimic calcifications on patient mammograms.

    Product
    TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2831-2018·2018-08-22

    Beekley S-SPOT REF 777 Mammography Markers Recalled for Imaging Artifacts

    Beekley Corporation is recalling S-SPOT REF 777 and 777S markers because they may create imaging artifacts that mimic calcifications on mammograms.

    Product
    S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2080-2012·2012-08-01

    Beekley Bella Blanket Mammography Coverlet Recalled for Imaging Artifacts

    Beekley Corporation is recalling Bella Blanket Protective Coverlets used in mammography because they can cause imaging artifacts on results.

    Product
    Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.
    Category
    Medical Device
    Distribution
    Distributed nationwide