The Recall Desk

Hazard

Imaging Inaccuracy recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2026-05-06

Of the 5 imaging inaccuracy 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 inaccuracy 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.

1–5 of 5

  • HighFDA (Devices)·Z-1951-2026·2026-05-06

    Philips Achieva 1.5T MRI Scanner Stiffness Calculation Error Recall

    Philips is recalling Achieva 1.5T MRI systems with MR Elastography software due to potential stiffness value errors that may occur with specific image reconstruction parameters, causing incorrect voxel size display in the default scan protocol.

    Product
    Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2024·2024-03-13

    Synapse PACS Software Version 7.2.000 Measurement Error in Breast Imaging

    FUJIFILM's Synapse PACS Version 7.2.000 produces incorrect measurements in breast imaging when analyzing Secondary Capture 2D images lacking pixel spacing information. Affected healthcare facilities should discontinue use for breast imaging measurements.

    Product
    Synapse PACS - Version 7.2.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1109-2019·2019-04-17

    Elekta Unity MRI Radiation Therapy System Recalled for Image Protocol Issues

    Elekta Limited is recalling 12 Unity MRI-guided radiation therapy systems because acquired images may not represent average anatomy during respiratory motion, potentially affecting treatment accuracy.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2498-2018·2018-08-01

    Philips Allura Xper Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Allura Xper systems because shutter positions reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as
    Category
    Medical Device
    Distribution
    Distributed nationwide