Philips Allura Xper Interventional Fluoroscopy Systems Recalled for Incorrect Bolt
Philips Allura Xper systems contain an incorrect half-threaded bolt in LTE kits instead of the required full-threaded bolt. Six units distributed worldwide have been affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported injuries or illnesses. It represents a risk-of-harm product where equipment malfunction is possible but injury has not yet been reported, meeting the rubric criterion for severity score 3 (High).
Plain-English summary
Philips Medical Systems Nederland B.V. has recalled certain Philips Allura Xper systems (R8.1 with Poly-G Stand) interventional fluoroscopic X-ray systems. The affected models are 722010, 722012, and 722013.
The LTE kits included with these systems contain a half-threaded bolt instead of the correct full-threaded bolt. This incorrect component may affect proper equipment assembly and functionality.
Six units have been distributed worldwide, including locations in Illinois and Oregon in the United States, as well as in Hungary, Ireland, Poland, and the United Kingdom. Affected serial numbers are 111, 138, 467, 817, 2928, and 269.
Healthcare facilities and operators of these systems should contact Philips Medical Systems for guidance on obtaining the correct component and instructions for remedy.
The recalled product
- Product
- Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 111 138 467 817 2928 269
Distribution
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