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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper and Azurion X-ray Systems Recalled for Monitor Image Defects

Agency Publication Date: February 16, 2024
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Summary

Philips Medical Systems is recalling 3,986 Allura Xper and Azurion Interventional Fluoroscopic X-ray systems due to a malfunctioning framegrabber card. This hardware defect can cause the medical monitor to show distorted or frozen images, or even no image at all, which may prevent doctors from switching between views during critical medical procedures. These systems were distributed worldwide and across the United States; the recall specifically affects the PC components known as the FlexVision PC and FlexViewing PC within the systems.

Risk

If the monitor fails or freezes during a procedure, it can result in significant delays while medical staff troubleshoot or switch to backup systems. Such delays during interventional X-ray procedures could pose a risk to patient safety, particularly during time-sensitive operations.

What You Should Do

  1. Identify if your medical facility uses the Philips Allura Xper or Azurion Interventional X-ray Systems.
  2. Check the PC component (FlexVision or FlexViewing PC) in the Disk Bay for affected model numbers, including Allura Xper FD10 (722003, 722010, 722026), FD20 (722006, 722012, 722028), and Azurion models 7 B12 (722067), 7 B20 (722068), 7 M12 (722078), and 7 M20 (722079).
  3. Verify the specific Serial Number and UDI-DI of your system against the extensive list provided in the recall notice to confirm if your specific unit is affected.
  4. Contact your healthcare provider or Philips Medical Systems Nederland B.V. immediately if you experience monitor distortion, frozen viewports, or the inability to switch views.
  5. Follow any specific technical instructions provided by Philips in the notification letter sent to affected customers regarding the repair or replacement of the framegrabber card.
  6. For additional information or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction and potential repair/replacement of the framegrabber card.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Philips Allura Xper Interventional Fluoroscopic X-ray Systems (FlexVision PC)
Model / REF:
722003
722010
722026
722005
722011
722027
722006
722012
722028
722008
722013
722025
722023
722035
722029
722058
722059
722038
722039
Lot Numbers:
Serial Numbers: 1181, 1187, 1311, 1349, 1435, 1594, 1700, 1788, 268, 285, 368, 390, 445, 467, 472, 485, 913, 940
UDI-DI 00884838059030
UDI-DI 00884838054189
UDI-DI 00884838054196
UDI-DI 00884838059115
UDI-DI 00884838059054
UDI-DI 00884838059191
UDI-DI 00884838059207
UDI-DI 00884838054202
UDI-DI 00884838059269
UDI-DI 00884838059061
UDI-DI 00884838080805
UDI-DI 00884838059085
UDI-DI 00884838054240
UDI-DI 00884838054219
UDI-DI 00884838059122
UDI-DI 00884838054226
Product: Philips Azurion Interventional Fluoroscopic X-ray Systems (FlexViewing PC)
Model / REF:
722067
722068
722078
722223
722079
Lot Numbers:
UDI-DI 00884838059290
UDI-DI 00884838064775
UDI-DI 00884838085350
UDI-DI 00884838085367
UDI-DI 00884838085251
UDI-DI 00884838099241
UDI-DI 00884838059221
UDI-DI 00884838085268
UDI-DI 00884838086777

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93783
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Authorized Philips medical equipment distributors; Direct B2B sales to hospitals and clinics
Manufactured In: Netherlands
Units Affected: 2 products (1,993 US; 2,662 OUS; 1,993 US; 2,662 ROW)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.