FDA Device recall Z-1076-2026
Allura Xper FD20/10
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of Allura Xper FD20/10 by Philips Medical Systems Nederland B V, citing philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1076-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-15 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Allura Xper FD20/10; Model Number: 722029;
Reason
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Identifiers
| code_info | Model Number: 722029; System Product Name: Allura Xper FD20/10; UDI-DI: 00884838054219; Serial Numbers: 30, 81, 80, 47; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1076-2026%22
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