The Recall Desk

Hazard

Imaging Loss recalls

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

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2026-06-10

Of the 13 imaging loss 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 loss 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.

1–13 of 13

  • HighFDA (Devices)·Z-2288-2026·2026-06-10

    Philips Azurion 7B12 Roadmap Pro may produce unusable dark images

    Philips Azurion 7B12/12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

    Product
    Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2026·2026-06-10

    Philips Azurion 5M20 Roadmap Pro may produce unusable dark images

    Philips Azurion 5M20 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

    Product
    Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2026·2026-06-10

    Philips Azurion 7M20 Roadmap Pro may produce unusable dark images

    Philips Azurion 7M20 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

    Product
    Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2026·2026-06-10

    Philips Azurion 3M12 Roadmap Pro may produce unusable dark images

    Philips Azurion 3M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

    Product
    Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2026·2026-06-10

    Philips Azurion 7M12 Roadmap Pro may produce unusable dark images

    Philips Azurion 7M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

    Product
    Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2026·2026-06-03

    Philips Allura system hard drives may degrade and lose imaging

    Philips Allura Xper interventional X-ray systems are being recalled because hard drives in the system PCs may lose performance as they age, potentially causing loss of imaging functionality.

    Product
    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2026·2026-06-03

    Philips Azurion system hard drives may degrade and lose imaging

    Philips Azurion interventional X-ray systems are being recalled because hard drives in the system PCs may lose performance as they age, potentially causing loss of imaging functionality.

    Product
    Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2025·2025-08-06

    Philips Allura R8.2.x systems may temporarily lose x-ray imaging functionality

    Philips Allura R8.2.x systems are being recalled because of the potential for temporary loss of imaging (X-ray) functionality due to a software issue. 4,508 units are affected.

    Product
    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2534-2024·2024-08-14

    Philips Azurion X-ray System: Potential Loss of Imaging Functionality

    The Philips Azurion Interventional Fluoroscopic X-ray System may lose imaging functionality or experience longer restart times. The FDA is recalling approximately 3,011 units of this device worldwide.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2026-2024·2024-06-12

    Surgical imaging device electrical component may intermittently shut off

    The O-arm O2 surgical imaging system may experience intermittent electrical failure affecting intraoperative imaging guidance. The recall involves 20 units distributed in the US and internationally.

    Product
    O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2024·2024-02-07

    Philips Azurion X-ray System Software Issue Causes Restart and Imaging Loss

    Philips Azurion interventional x-ray systems may continuously restart due to a software issue, causing loss of imaging functionality and data. If this occurs during a procedure, the procedure may be delayed or aborted.

    Product
    Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2476-2021·2021-09-22

    Philips Azurion Imaging System Failure at 480V Hospital Power Supply

    Philips Azurion medical imaging devices may fail when powered by hospital electrical systems providing 480V. The failure reduces X-ray performance and may be preceded by a burning smell.

    Product
    The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1904-2021·2021-06-30

    Philips Allura Xper System power supplies may fail unexpectedly

    Certain low-voltage power supplies in Philips Allura Xper interventional X-ray systems may fail, potentially causing loss of imaging functionality. 42 devices are affected worldwide.

    Product
    Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
    Category
    Medical Device
    Distribution
    10 states