The Recall Desk

Hazard

Image Orientation Error recalls

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

What the numbers show

Total
17
Critical
0
Severe
0
Most recent
2025-05-28

Of the 17 image orientation 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 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 orientation 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.

1–17 of 17

  • HighFDA (Devices)·Z-1785-2025·2025-05-28

    True 3D Viewer Model EP-00003 Software Orientation Display Issue Recall

    Echopixel's True 3D Viewer (Model EP-00003) with certain software versions can display ultrasound image orientation incorrectly, potentially leading to misdiagnosis or incorrect surgical planning.

    Product
    True 3D Viewer, Model: EP-00003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0050-2025·2024-10-16

    StealthStation S8 Spine Surgery Navigation System Recalled for Software Defects

    Medtronic is recalling 1,801 StealthStation S8 surgical navigation systems due to software anomalies that can flip navigation images during spine surgery and prevent warning messages for suboptimal imaging settings.

    Product
    StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0640-2024·2024-01-17

    Philips Incisive CT Scanner Software Issues May Cause Misdiagnosis

    Philips is recalling Incisive CT scanners due to nine software defects including image artifacts, incorrect orientation labels, display failures, and positioning errors that could lead to misdiagnosis or need for rescans. No illnesses have been reported.

    Product
    Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2023·2023-05-31

    Philips Incisive CT System Recalled for Potential Image Orientation Error

    Philips recalls the Incisive CT whole-body X-Ray imaging system in 22 units due to potential incorrect image orientation that could result in flipped or reversed images, leading to misdiagnosis, incorrect treatment, or unnecessary radiation exposure.

    Product
    Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1622-2023·2023-05-31

    Philips CT Scanner May Display Images With Incorrect Orientation

    Philips Incisive CT X-ray systems may display medical images in incorrect orientation, potentially leading to misdiagnosis, incorrect treatment, and unnecessary radiation exposure if rescans are needed.

    Product
    Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1563-2022·2022-09-07

    Philips Radiography System Firmware Defect Risks Incorrect Radiation Dose

    Philips DigitalDiagnost C50 1.1 radiography systems contain a firmware defect in the Wallstand VS2 board that may cause incorrect radiation dose and anatomic marker misalignment. Eleven affected systems were distributed nationwide.

    Product
    DigitalDiagnost C50 1.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2022·2022-07-20

    Radiography System Firmware Error May Cause Incorrect Radiation Dose

    Philips DigitalDiagnost 4 radiography systems may deliver incorrect radiation doses due to a Wallstand VS2 firmware issue causing incorrect image orientation and misaligned anatomical markers.

    Product
    DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2021·2021-07-21

    MRI System Patient Orientation Button Click Error May Flip Images

    GE Healthcare is recalling 1,519 Optima MR450w MRI systems worldwide due to a button interface error. The 'Patient Orientation' button may be unintentionally clicked instead of 'Save RX,' causing incorrectly oriented or flipped diagnostic images.

    Product
    Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2058-2021·2021-07-21

    MRI Imaging System UI Defect May Cause Incorrect Image Orientation

    GE Healthcare recalled 1,737 SIGNA Creator and SIGNA Explorer MRI systems due to a software bug where the 'Patient Orientation' button can be accidentally clicked instead of 'Save RX,' potentially causing incorrectly oriented diagnostic images.

    Product
    SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2057-2021·2021-07-21

    GE Healthcare SIGNA PET/MR button mix-up causes image orientation errors

    GE Healthcare is recalling 71 SIGNA PET/MR imaging devices worldwide. A software issue allows the Patient Orientation button to be accidentally clicked instead of Save RX, resulting in incorrectly annotated or flipped diagnostic images.

    Product
    SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2055-2021·2021-07-21

    MRI Scanner Patient Orientation Button Confusion Affects Images

    GE Healthcare's MRI scanners may have a button confusion issue where the Patient Orientation button is accidentally clicked instead of Save RX, potentially causing misoriented or incorrectly annotated images. 585 devices affected worldwide.

    Product
    Discovery MR750w 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-2060-2021·2021-07-21

    SIGNA MR380 MRI System Patient Orientation Button May Click Unintentionally

    GE Healthcare is recalling the SIGNA MR380 MRI system due to a user interface flaw where the Patient Orientation button may be inadvertently clicked instead of the Save RX button. This can result in incorrectly annotated or flipped MRI images.

    Product
    SIGNA MR380, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2050-2018·2018-06-13

    NordicNeuroLab Recalls nordicBrainEx 2.0 Software Due to Image Orientation Errors

    NordicNeuroLab AS is recalling nordicBrainEx 2.0 software versions 2.1 and older because a DICOM header error may cause incorrect image orientation labeling.

    Product
    nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2044-2018·2018-06-06

    NordicNeuroLab Recalls nordicICE 2.3.14 Image Processing Software

    NordicNeuroLab AS is recalling 97 licenses of nordicICE 2.3.14 image processing software due to a defect that may cause incorrect orientation labeling and image flipping.

    Product
    nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0169-2014·2013-11-13

    Vital Images Recalls VitreaCore Software Due to Image Orientation Defect

    Vital Images, Inc. is recalling VitreaCore software versions 6.0 through 6.5 due to a potential for incorrect or reversed image orientation in certain snapshots.

    Product
    VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2012·2012-10-03

    Hologic Fluoroscan Mini C-Arm Software Recall for Image Orientation Errors

    Hologic is recalling Fluoroscan Mini C-Arm devices with specific InSight software versions because DICOM images may be flipped 180 degrees when stored in PACS systems.

    Product
    Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2012·2012-10-03

    Hologic Fluoroscan Mini C-Arm Recalled for Flipped DICOM Images

    Hologic is recalling Fluoroscan Mini C-Arm devices with InSight2 software versions 4.0 and 4.0.1 because DICOM images stored in PACS may be flipped 180 degrees.

    Product
    Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and
    Category
    Medical Device
    Distribution
    Distributed nationwide