Allura Xper FD — Class II medical device recall Z-2928-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2026-08-19, distributed nationwide. Firmware issue potentially leading to loss of geometry movements.
| Recall number | Z-2928-2026 |
|---|---|
| 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 | 2026-06-29 |
| Classified | 2026-08-10 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LK, LT, MA, MT, MX, MY, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SE, SG, SK, TH, TN, TT, TW, UA, UY, VN, ZA |
| Quantity | 4,252 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838054189, 00884838054196, 00884838054202, 00884838054219, 00884838054226, 00884838054271, 00884838059115 |
| Model numbers | 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058 |
Product
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Reason for recall
Firmware issue potentially leading to loss of geometry movements.
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-2928-2026. 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.