FDA Device recall Z-2716-2024
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
- FDA Device
- Class II
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class II recall of Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013 by Philips Medical Systems Nederland B V, citing A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2716-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-08 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
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.
Identifiers
| code_info | Serial Numbers: 111 138 467 817 2928 269 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2716-2024%22
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