Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper… Recall
Issued December 18, 2024 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
In December 2024, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled the Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.
What you should do
- 1 Stop using Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Health
- Recall date
- December 18, 2024
- Units affected
- Not reported
- Sold at
- Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Br
- Recall number
- FDA-Z-0676-2025
- Made in
- Netherlands
- Issuing agency
- FDA
In context
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 17 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.