The Recall Desk

Hazard

Image Quality Defect recalls

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

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2025-05-28

Of the 8 image quality 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 image quality 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.

1–8 of 8

  • HighFDA (Devices)·Z-1805-2025·2025-05-28

    Philips MR 7700 Medical Device Alignment Error in MobiView Application

    Philips is recalling MR 7700 model medical devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3248-2024·2024-10-02

    Hologic Recalls Selenia Dimensions and 3Dimensions Breast Imaging Software

    Hologic is recalling Selenia Dimensions and 3Dimensions software due to a defect that may cause blurry images and potential misdiagnosis.

    Product
    Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2024·2023-11-29

    Boston Scientific EXALT Model D Duodenoscope Recall: Fluid Ingress in Lens

    Boston Scientific is recalling certain EXALT Model D Single-Use Duodenoscopes worldwide due to fluid ingress in the lens, which causes poor image quality. Affected devices should not be used; contact the manufacturer.

    Product
    EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2835-2018·2018-08-22

    Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Defect

    Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller due to improper calibration. The defect may cause dim images, color imbalance, or increased fogging.

    Product
    The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1891-2018·2018-05-23

    Volcano CORE M2 Vascular System Recalled for Incorrect Resistor

    Volcano Corporation is recalling eight Philips Volcano CORE M2 Vascular Systems because an incorrect resistor causes noise and overly bright images.

    Product
    Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0011-2017·2016-10-12

    Philips Ingenuity Core 128 CT Scanner Recalled for Image Quality Defects

    Philips Medical Systems is recalling 524 Ingenuity Core 128 CT scanners because high-resolution head scans may produce degraded image quality, including non-uniformity and CT number shifts.

    Product
    Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product 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-0010-2017·2016-10-12

    Philips CT Scanner Recall for Infant Head Image Quality Defects

    Philips is recalling 358 Ingenuity Core CT scanners because infant head scans may show degraded image quality, including non-uniformity and CT number shifts.

    Product
    Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product 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-0820-2015·2014-12-24

    Carestream DirectView CR Software Recalled for Reduced Mammographic Image Quality

    Carestream Health is recalling 59 units of DirectView CR Software due to reduced image quality when printing true size multi-format images.

    Product
    CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
    Category
    Medical Device
    Distribution
    3 states