Philips DXR System — Class II medical device recall Z-1554-2025
Ongoing recall by Philips North America Llc, reported 2025-04-23, distributed nationwide. Potential for collimator to fall as a result of incorrect installation.
| Recall number | Z-1554-2025 |
|---|---|
| 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 | 2025-03-10 |
| Classified | 2025-04-11 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CL, CN, DE, ES, GB, HU, ID, IN, IT, KE, MX, NL, NZ, OM, PE, PK, PL, RO, SI, TH, VN, ZA |
| Quantity | 83 units |
| UPC / GTIN / UDI-DI | 00884838064751 |
| Serial numbers | 200037, 200089, SN160061, SN160096, SN170009, SN170010, SN180020, SN180045, SN180072, SN180075 |
| Model numbers | 712214 |
Product
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Reason for recall
Potential for collimator to fall as a result of incorrect installation.
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-1554-2025. 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.