The Recall Desk

Hazard

Image Quality 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
0
Most recent
2026-04-22

Of the 16 image quality 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 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-1814-2026·2026-04-22

    ARTIS Pheno 3D acquisitions may capture uneven patient image brightness

    ARTIS Pheno VE30A and VE40A systems are being recalled because 3D acquisitions may capture lighter and darker images, reducing reconstruction accuracy. 73 units are affected.

    Product
    ARTIS Pheno VE30A and VE40A, Model 10849000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0241-2026·2025-10-29

    Interventional fluoroscopy systems recalled over control board corrosion affecting imaging

    Philips is recalling 29 Zenition 50 interventional fluoroscopic X-ray systems because corrosion of the image intensifier television control board may cause loss of imaging or poor image quality.

    Product
    Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1803-2025·2025-05-28

    Philips Ingenia Elition X MRI System Alignment Error Recall

    Philips has recalled specific Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2024·2023-11-29

    EXALT Model D Single-Use Duodenoscope Recalled for Lens Fluid Ingress

    Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes due to fluid ingress in the lens, which causes poor image quality during procedures.

    Product
    EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1492-2021·2021-05-05

    Boston Scientific Recalls EXALT Controllers Due to Suboptimal Brightness Settings

    Boston Scientific is recalling three EXALT Controllers because they may have been programmed with suboptimal brightness settings, resulting in darker than desired images.

    Product
    EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2819-2020·2020-08-26

    United Imaging uMI 550 PET/CT Systems Recalled for Software Display Issue

    Shanghai United Imaging Healthcare Co., Ltd. is recalling three uMI 550 PET/CT systems because a software defect may prevent the CT Hounsfield unit curve from displaying in real time during specific scans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2019·2019-05-29

    KaVo Recalls DEXIS Titanium Intraoral Sensors Due to Calibration Error

    KaVo Dental Technologies is recalling 211 DEXIS Titanium Intraoral Sensors because incorrectly programmed calibration files may reduce image quality.

    Product
    DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1045-2017·2017-01-25

    DICOM GRID Recalls Ambra PACS Software Due to Image Display Error

    DICOM GRID Inc. is recalling Ambra PACS software version V3.16.13.0 because a defect causes diagnostic images to appear washed out, potentially affecting image analysis.

    Product
    Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2655-2016·2016-08-31

    Philips Brilliance 16 CT Scanner Recalled for Image Reconstruction Defect

    Philips Medical Systems is recalling 192 Brilliance 16 CT scanners because a software upgrade can cause planned anatomy to be cut off in images, potentially requiring a rescan.

    Product
    Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-ray systems intended to produce 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-2653-2016·2016-08-31

    Philips Brilliance CT Big Bore Oncology Software Recall

    Philips is recalling 33 Brilliance CT Big Bore Oncology systems due to a software defect that may cause planned anatomy to be cut off in gated helical CT images.

    Product
    Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce 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-0021-2016·2015-10-14

    Siemens SOMATOM Definition AS CT Scanner Software Recall

    Siemens Medical Solutions is recalling 113 SOMATOM Definition AS CT scanners to fix a software bug affecting visual warnings and image quality.

    Product
    SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2016·2015-10-14

    Siemens SOMATOM Definition Flash CT Scanner Software Recall

    Siemens Medical Solutions USA is recalling 113 SOMATOM Definition Flash CT scanners due to a software bug in version VA48A_SP0 that affects visual warnings and image quality.

    Product
    SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0019-2016·2015-10-14

    Siemens SOMATOM Definition Edge CT Scanner Software Recall

    Siemens Medical Solutions is recalling 113 SOMATOM Definition Edge CT scanners due to a software bug affecting visual warnings and image quality.

    Product
    SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2015·2015-08-05

    Philips CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 82 Ingenuity Core CT systems due to software errors affecting image quality, dose control, and heart rate monitoring.

    Product
    Computed Tomography X-ray Systems Ingenuity Core. Intended to produce 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
  • HighFDA (Devices)·Z-1940-2013·2013-08-21

    GE LightSpeed CT750 HD Recalled for CT Number Variance and Software Issues

    GE Healthcare is recalling 244 GE LightSpeed CT750 HD systems due to CT number variance in head perfusion images and software defects.

    Product
    GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1598-2013·2013-07-17

    Toshiba Kalare Diagnostic X-Ray System Recalled for Image Quality Defect

    Toshiba American Medical Systems is recalling 153 Kalare Diagnostic X-Ray Systems because the large focus heats up unexpectedly, causing brighter images than expected.

    Product
    TOSHIBA Kalare Diagnostic X-Ray System K110785
    Category
    Medical Device
    Distribution
    Distributed nationwide