Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper Fluoroscopic X-Ray Systems Recalled for Incorrect Bolt in Kit

Agency Publication Date: August 22, 2024
Share:
Sign in to monitor this recall

Summary

Philips Medical Systems Nederland B.V. is recalling 6 Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray Systems because a half-threaded bolt was accidentally included in LTE kits instead of the required full-threaded bolt. The affected model numbers include 722010, 722012, and 722013. This mechanical error could affect the structural integrity or assembly of the X-ray stand. Consumers and healthcare facilities should contact the manufacturer immediately to address this assembly defect.

Risk

The inclusion of an incorrect half-threaded bolt instead of a full-threaded bolt may prevent the system components from being properly secured. This could lead to mechanical instability of the interventional fluoroscopic X-ray stand during medical procedures.

What You Should Do

  1. Identify if your facility uses a Philips Allura Xper system (R8.1 with Poly-G Stand) by checking the model numbers: 722010, 722012, or 722013.
  2. Verify your system's serial number against the affected list: 111, 138, 467, 817, 2928, or 269.
  3. Immediately contact Philips Medical Systems Nederland B.V. or your local Philips service representative to arrange for an inspection and the installation of the correct full-threaded bolt.
  4. Consult with your facility's biomedical engineering department or your healthcare provider to determine if any procedures need to be rescheduled until the system is verified.
  5. For further information or technical support, contact the manufacturer directly at their Netherlands headquarters or through your regional Philips Medical Systems service channel.
  6. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Correction

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

Affected Products

Product: Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System
Model / REF:
722010
722012
722013
Lot Numbers:
Serial Numbers: 111 138 467 817 2928 269

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95144
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Philips Medical Systems
Manufactured In: Netherlands
Units Affected: 6 units
Distributed To: Illinois, Oregon

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.