CombiDiagnost R90 1 — Class II medical device recall Z-1355-2023
Ongoing recall by Philips North America Llc, reported 2023-04-19, distributed nationwide. If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main-
| Recall number | Z-1355-2023 |
|---|---|
| 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 | 2021-10-21 |
| Classified | 2023-04-10 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 512 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838076747, 00884838101456 |
| Serial numbers | 10000000, 10000001, 10000002, 10000003, 10000004, 10000006, 10000007, 10000010, 10000011, 10000012, 10000013, 10000014, 10000015, 10000016, 10000019, 10000020, 10000021, 10000022, 10000023, 10000024, 10000025, 10000026, 10000027, 10000029, 10000030 and 451 more |
| Model numbers | 709030, 709031 |
Product
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Reason for recall
If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.
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-1355-2023. 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.