DigitalDiagnost 4 — Class II medical device recall Z-0464-2026
Ongoing recall by Philips Medical Systems DMC GmbH, reported 2025-11-19, distributed nationwide. Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through J
| Recall number | Z-0464-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems DMC GmbH, Hamburg, Germany |
| Recall initiated | 2025-10-01 |
| Classified | 2025-11-07 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, CA, CH, CL, DE, DK, EE, ES, FI, FR, GB, GH, HR, ID, IL, IQ, IT, JO, KR, KW, LT, LV, NL, NO, NZ, PA, PH, PL, PT, SA, SE, SG, ZA |
| Quantity | 12 units |
| UPC / GTIN / UDI-DI | 00884838065321, 00884838074514 |
| Serial numbers | 10001179, 10001181, 10001182, 10001185, 10001186, 10001188, 10001189, 19000341, 19000342, 19000343, SN16000022, SN20000013 |
| Model numbers | 712031, 712032 |
Product
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
Reason for recall
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
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-0464-2026. 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.