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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 Systems Recalled Due to Table Pivot Brake Failure

Agency Publication Date: May 24, 2024
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Summary

Philips Medical Systems is recalling five Allura Xper FD10, FD20, and FD20 Biplane medical imaging systems because a specific software update (version 8.1.100) prevents the table's pivot brake from engaging. When installed on systems with an AD7NT non-tilt table, this defect can cause the patient table to move unexpectedly during medical procedures. Only five units are affected globally, including one unit in the United States. Owners should contact Philips Medical Systems for technical support and to arrange for a software correction.

Risk

The failure of the pivot brake allows the patient table to move without warning, which could lead to patient injury or complications during sensitive imaging or surgical procedures.

What You Should Do

  1. Identify if your facility has a Philips Allura Xper FD10, FD20, or FD20 Biplane system with an ADN7NT patient table by checking the model and serial numbers.
  2. For the FD20 system, check for Product number 722012, UDI/DI 00884838059054, and Serial Number 2138.
  3. For the FD10 systems, check for Product number 722010, UDI/DI 00884838059030, and Serial Numbers 774, 909, or 526.
  4. For the FD20 Biplane system, check for Product number 722013, UDI/DI 00884838059061, and Serial Number 232.
  5. Verify if Software Version 8.1.100 is currently installed on your system.
  6. If your system is affected, contact Philips Medical Systems Nederland B.V. or your local Philips representative immediately to schedule a software fix.
  7. Contact the FDA at 1-888-463-6332 if you have additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for software correction

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

Affected Products

Product: Philips Allura Xper FD20 system with an ADN7NT patient table
Model / REF:
722012
UPC Codes:
00884838059054
Lot Numbers:
Serial Number: 2138
Product: Philips Allura Xper FD10 system with an ADN7NT patient table
Model / REF:
722010
UPC Codes:
00884838059030
Lot Numbers:
Serial Numbers: 774, 909, 526
Product: Philips Allura Xper FD20 Biplane system with an ADN7NT patient table
Model / REF:
722013
UPC Codes:
00884838059061
Lot Numbers:
Serial Number: 232

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94647
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: authorized medical distributors
Manufactured In: Netherlands
Units Affected: 3 products (1 unit (US); 3 units (OUS); 1 unit (OUS))
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.