Allura Xper FD20/20 — Class II medical device recall Z-1077-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2026-01-21, distributed nationwide. Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was
| Recall number | Z-1077-2026 |
|---|---|
| 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 | 2025-12-15 |
| Classified | 2026-01-13 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BE, BR, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EC, EG, ES, FR, GB, GR, GT, HN, IN, IT, JP, KE, KR, KY, LK, MX, MY, NL, NP, OM, PA, PE, PH, PK, PL, PY, QA, RO, SA, SG, TH, TR, TW, VE, ZA |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 00884838054226 |
| Serial numbers | 110, 117, 124, 134 |
| Model numbers | 722038 |
Product
Allura Xper FD20/20; Model Number: 722038;
Reason for recall
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
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-1077-2026. 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.