Philips Allura Xper systems — Class II medical device recall Z-2716-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-08-28, distributed nationwide. A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
| Recall number | Z-2716-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands |
| Recall initiated | 2024-08-08 |
| Classified | 2024-08-22 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, HU, IE, PL |
| Quantity | 6 units |
| Serial numbers | 111, 138, 269, 2928, 467, 817 |
| Model numbers | 722010, 722012, 722013 |
Product
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Reason for recall
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2716-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.