FDA Device recall Z-1077-2025
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026 by Philips Medical Systems Nederland B V, citing potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the pa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1077-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-13 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
Reason
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Identifiers
| code_info | UDI: (1) 722003 00884838059191(10); (2) 722010 00884838059030(21); (3)722026 00884838054189(21). |
|---|
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-1077-2025%22
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