CombiDiagnost R90 R1 — Class II medical device recall Z-1589-2023
Ongoing recall by Philips North America, reported 2023-05-24, distributed nationwide. Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiag
| Recall number | Z-1589-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-03-03 |
| Classified | 2023-05-15 |
| Reported by FDA | 2023-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 25 systems |
| Reason classes | labeling |
| Serial numbers | 10001071, 10001072, 10001086, 10001087, 10001114 |
| Model numbers | 709031 |
Product
CombiDiagnost R90 R1.1
Reason for recall
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
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-1589-2023. 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.