Philips OMNI III TEE Ultrasound Transducer — Class III medical device recall Z-1624-2026
Ongoing recall by Philips Ultrasound, Inc, reported 2026-04-01, distributed nationwide. To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
| Recall number | Z-1624-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, Inc, Reedsville, PA, United States |
| Recall initiated | 2025-09-05 |
| Classified | 2026-03-24 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 75 units |
| UPC / GTIN / UDI-DI | 00884838067585, 00884838067646, 00989803001561 |
| Serial numbers | 02CGWH, 02D9TH, 02DCH7, 02DFBP, 02DG0D, 02GR5B, 02JJ0T, 02JJ6T, 02JL01, 02JP4Z, 02JQPG, 02P8GV, 02PCMT, 02QGKV, 02QK2L, 02QLMQ, 02VN40, 02VTGK, 02VWNV, 02WCTB, 02WH6F, 02WMD4, 02Y7HM, 02YCFD, 02ZTTT and 50 more |
| Model numbers | 989605440701, 989605440702, 989605440772, 989803001561 |
Product
Philips OMNI III TEE Ultrasound Transducer
Reason for recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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-1624-2026. 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.