Wireless Footswtich used with the following Philips Allura Xper and… — Class II medical device recall Z-0476-2022
Ongoing recall by Philips North America Llc, reported 2022-01-19, distributed nationwide. Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure
| Recall number | Z-0476-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-10-29 |
| Classified | 2022-01-10 |
| Reported by FDA | 2022-01-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, CA, CH, CL, CN, CR, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IR, IT, JP, KR, KW, LB, LV, MX, NL, NO, NZ, OM, PH, PK, PL, PT, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, VN, ZA |
| Model numbers | 459801238191, 459801238201, 459801238211, 459801238221, 459801238231, 459801238241, 459801238251, 459801238261, 459801257861, 459801319361, 459801319371, 459801319391, 459801319421, 459801319431, 459801319441, 459801319471, 459801319481, 459801319511, 459801319521, 459801319531, 459801319541, 459801733051, 459801733061, 459801733071, 459801733081 and 48 more |
Product
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722065, 722066, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. Wireless footswitch Models: 459801319471, 459801319521, 459801319361, 459801319421, 459801319481, 459801319531, 459801319511, 459801319541, 459801319371, 459801319431, 459801319391, 459801319441, 459801238241, 459801238231, 459801238261, 459801238251, 459801238201, 459801238191, 459801238221, 459801238211, 459801733051, 459801733061, 459801733071, 459801733081, 459801257861, 459801733091
Reason for recall
Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure
Machine access
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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.