System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper… — Class II medical device recall Z-3166-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-09-25, distributed nationwide. Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts
| Recall number | Z-3166-2024 |
|---|---|
| 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 | 2024-08-22 |
| Classified | 2024-09-18 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, KY, LB, LK, LT, LV, MA, MT, MX, MY, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 9,318 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838054189, 00884838054196, 00884838054202, 00884838054219, 00884838054226, 00884838054240, 00884838055513, 00884838059030, 00884838059054, 00884838059061, 00884838059115, 00884838059122, 00884838059191, 00884838080805 |
Product
System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 Allura Xper FD20/10 722028 Allura Xper FD20 722027 Allura Xper FD10/10 722026 Allura Xper FD10 722025 Allura Xper FD20 Biplane OR Table 722023 Allura Xper FD20 OR Table 722020 Allura Xper FD20 Biplane OR Table 722015 Allura Xper FD20 OR Table 722013 Allura Xper FD20 Biplane 722012 Allura Xper FD20 722011 Allura Xper FD10/10 722010 Allura Xper FD10 722008 Allura Xper FD20 Biplane 722006 Allura Xper FD20 722005 Allura Xper FD10/10 722003 Allura Xper FD10 722002 Allura Xper FD10F 722001 Allura Xper FD10C
Reason for recall
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
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-3166-2024. 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.