FDA Enforcement
Class II
Ongoing
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Recall: Z-2716-2024
·
Reported August 28, 2024
Enforcement
- Recall Number
- Z-2716-2024
- Event ID
- 95144
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 28, 2024
- Initiation Date
- August 8, 2024
- Classification Date
- August 22, 2024
- Address
- Veenpluis 4-6, Best, N/A, Netherlands
Description
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Reason
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Code Info
Serial Numbers: 111 138 467 817 2928 269
Distribution
Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
Quantity
6 units