FDA Device recall Z-0014-2026
Allura Xper CV20
- FDA Device
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of Allura Xper CV20 by Philips Medical Systems Nederland B V, citing the BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the sy….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0014-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-03 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Reason
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Identifiers
| code_info | Model Numbers: 722031; UDI-DI: N/A; Serial Numbers: 29, 77, 23, 18, 45, 90, 164, 30, 76, 32, 75, 33, 40, 13, 113, 111,…Model Numbers: 722031; UDI-DI: N/A; Serial Numbers: 29, 77, 23, 18, 45, 90, 164, 30, 76, 32, 75, 33, 40, 13, 113, 111, 46, 25, 130, 26, 61, 78, 42, 167, 49, 64, 41, 71, 20, 17, 63, 39, 9, 55, 36, 73, 48, 53, 31, 96, 28, 154, 166, 15, 84, 47, 35, 24, 148, 50, 79, 62, 66; |
|---|
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-0014-2026%22
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