The Recall Desk

Hazard

Imaging Error recalls

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

What the numbers show

Total
16
Critical
0
Severe
1
Most recent
2025-03-19

Of the 16 imaging error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) 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 error 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.

1–16 of 16

  • HighFDA (Devices)·Z-1324-2025·2025-03-19

    Philips Spectral CT on Rails software recall due to scanning and movement issues

    Philips is recalling one unit of Spectral CT on Rails software version 5.1.0 due to multiple software problems causing scanning issues, image errors, and unintended device movement.

    Product
    Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-3126-2024·2024-09-18

    Proton Beam Therapy System Displays Insufficient CBCT Images on Button Press

    Hitachi's PROBEAT-CR proton therapy system may display insufficient CBCT images during image positioning when the Float Image Selection button is pressed. This could affect treatment planning accuracy.

    Product
    Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2022·2021-11-10

    Artis zeego X-Ray System Software Error Affects Image Reconstruction

    Siemens Artis zeego fluoroscopic X-ray systems have a software error that incorrectly displays 3D image reconstruction when the patient table is rotated more than 4 degrees, potentially resulting in incorrect patient treatment during image-guided procedures.

    Product
    Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2021·2021-07-21

    GE Discovery MR750 MRI Scanner Button Error May Produce Flipped Images

    GE Healthcare recalled 248 units of the Discovery MR750 3.0T scanner due to a button-confusion error where the Patient Orientation button may be clicked instead of Save RX, potentially resulting in incorrectly oriented or flipped images. No injuries reported.

    Product
    Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2898-2020·2020-09-02

    Siemens E.cam and Symbia Systems Recalled for Detector Time Loss

    Siemens Medical Solutions is recalling E.cam and Symbia systems with foresight detectors because they may lose detector time information during gated or dynamic acquisitions.

    Product
    E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2020·2020-02-19

    Philips VesselNavigator Software Recall for DSA Display Defect

    Philips is recalling VesselNavigator software due to a defect that displays digital subtraction angiography images without subtraction.

    Product
    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extension
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2019·2019-02-13

    GE Healthcare Recalls Revolution CT Systems with SmartStep Option

    GE Healthcare is recalling 131 Revolution CT systems with the SmartStep Option because the displayed Z location may not match the actual table position, potentially causing scans at incorrect locations.

    Product
    Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0773-2019·2019-02-13

    NeuViz 128 CT Scanner Recalled for Potential Image Field of View Error

    Neusoft Medical Systems is recalling three NeuViz 128 CT scanners because a software defect may cause incorrect image field of view, potentially leading to misaligned clinical scans.

    Product
    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY tran
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0273-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems for Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D an
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2500-2018·2018-08-01

    Philips Centron Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Centron systems because shutter settings reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Centron 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 PTCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2016·2016-06-15

    Philips Brilliance iCT CT System Software Defect Recall

    Philips Healthcare is recalling Brilliance iCT Computed Tomography X-Ray Systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0407-2016·2015-12-23

    Philips CT Scanner Software Error May Alter Scan Length

    Philips is recalling 105 Ingenuity Core 128 CT scanners because software may unexpectedly change the scan length during specific protocols.

    Product
    Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0174-2016·2015-11-04

    Philips Recalls Brilliance 64 CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 108 Brilliance 64 CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts.

    Product
    Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1074-2014·2014-03-05

    Philips BrightView Gamma Cameras Recalled for Patient Contact Risk

    Philips is recalling 1,143 BrightView gamma cameras because a positioning error can cause detectors to contact patients during imaging.

    Product
    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2013·2013-08-28

    GE Healthcare Recalls Discovery NM/CT 570c Systems for Scanning Error

    GE Healthcare is recalling 10 Discovery NM/CT 570c systems in Connecticut after an incident where the wrong part of a patient's body was scanned during a CT exam.

    Product
    The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0931-2013·2013-03-20

    Elekta Synergy XVI Radiation Therapy Imager Recalled for DICOM Tag Defect

    Elekta, Inc. is recalling 164 Synergy XVI Radiation Therapy Digital Imagers because DICOM tags lack sufficient information to identify volumes with the same name.

    Product
    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
    Category
    Medical Device
    Distribution
    Distributed nationwide