FDA Device recall Z-2928-2026
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058
- FDA Device
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058 by Philips Medical Systems Nederland B V, citing firmware issue potentially leading to loss of geometry movements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2928-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-29 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Reason
Firmware issue potentially leading to loss of geometry movements.
Identifiers
| code_info | Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (0…Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838059115(21)100, (01)00884838059115(21)239, (01)00884838054202(21)520, (01)00884838054202(21)1956, (01)00884838054189(21)683, (01)00884838054196(21)351, (01)00884838054202(21)129, (01)00884838059115(21)305, (01)00884838054196(21)332, (01)00884838054202(21)1233, (01)00884838054202(21)2206, (01)00884838054202(21)1690, (01)00884838054202(21)928, (01)00884838054189(21)155, (01)00884838054202(21)317, (01)00884838054202(21)1774, (01)00884838054202(21)2502, (01)00884838054202(21)869, (01)00884838054202(21)668, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054202(21)406, (01)00884838054202(21)540, (01)00884838054202(21)548, (01)00884838054202(21)1017, (01)00884838054202(21)590, (01)00884838054189(21)654, (01)00884838054189(21)786, (01)00884838054196(21)216, (01)0088 |
|---|
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-2928-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.