Philips Interventional Hemodynamic Application R — Class II medical device recall Z-1926-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-06-05, distributed nationwide. Potential for pressure wave data synchronization from two devices may not be correct.
| Recall number | Z-1926-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands |
| Recall initiated | 2024-05-02 |
| Classified | 2024-05-30 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, CH, CL, CR, CZ, DE, EC, FR, GB, GR, HU, IE, IN, IT, KR, LK, MY, NL, NZ, OM, PA, PK, PL, RS, SA, SG, TH, UA, ZA |
| Quantity | 391 units |
| UPC / GTIN / UDI-DI | 00884838100084, 00884838101180 |
| Serial numbers | 1007, 101, 1015, 1020, 1021, 1022, 1032, 1033, 1037, 1039, 1040, 105, 1086, 1088, 1104, 1106, 1126, 1133, 1135, 1137, 1140, 1141, 1147, 1151, 1155 and 346 more |
| Model numbers | 722467 |
Product
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
Reason for recall
Potential for pressure wave data synchronization from two devices may not be correct.
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-1926-2024. 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.