Wireless Foot Switch distributed with Philips Allura Xper and Azurion… — Class II medical device recall Z-2485-2023
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2023-09-06, distributed nationwide. Loss of availability of the wireless foot switch during procedures.
| Recall number | Z-2485-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands |
| Recall initiated | 2023-06-30 |
| Classified | 2023-08-30 |
| Reported by FDA | 2023-09-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CH, CL, CN, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IR, IS, IT, JO, JP, KR, LB, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, UA, ZA |
| Quantity | 1,865 units |
| UPC / GTIN / UDI-DI | 00459800415574, 00459800772233 |
| Lot numbers | 459800415531, 459800415532, 459800415533, 459800415534, 459800415535, 459800415571, 459800415572, 459800415573, 459800415575, 459800772231, 459800772261, 459800772263 |
| Model numbers | 722001, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722023, 722025, 722026, 722027, 722028, 722029, 722033, 722035, 722038, 722039, 722058, 722059, 722064, 722065, 722066 and 4 more |
Product
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Reason for recall
Loss of availability of the wireless foot switch during procedures.
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-2485-2023. 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.