2D Perfusion — Class II medical device recall Z-1417-2023
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2023-04-26, distributed nationwide. There are technical issues related to signal generation and processing, which can lead to inaccurate presentat
| Recall number | Z-1417-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands |
| Recall initiated | 2023-02-20 |
| Classified | 2023-04-20 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00884838059276 |
| Model numbers | 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067, 722068, 722078, 722079, 722223, 722224, 722225 and 3 more |
Product
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
Reason for recall
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
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-1417-2023. 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.