Device product
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Z-2716-2024
Product summary
- Event
- Event 95144
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-2716-2024
Official wording
Reason: A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Code information: Serial Numbers: 111 138 467 817 2928 269
Distribution pattern: Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
Derived failure modes
-
Unknown
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.