FDA DevicesClass III
Philips OMNI III TEE Ultrasound Transducer
Published: April 1, 2026Recall ID: Z-1624-2026Category: devicesCountry: US
Reason for Recall / Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product Description & Identification
Philips OMNI III TEE Ultrasound Transducer
Additional Source Details
| Field | Value |
|---|---|
| City | Reedsville |
| State | PA |
| Event id | 97643 |
| Address 1 | 1 Echo Dr |
| Code info | Model No. 989605440701, 989605440702, 989605440772, 989803001561; UDI: (01)00884838067585(21)02ZTTT, (01)00884838067585(21)B0X7MD, (01)00884838067585(21)02VWNV, (01)00884838067585(21)02JQPG, (01)00884838067585(21)02PCMT, (01)00884838067585(21)0341PG, (01)00884838067585(21)02QLMQ, (01)00884838067585(21)B0JFCN, (01)00884838067585(21)03C009, (01)00884838067585(21)02Y7HM, (01)00884838067585(21)02VTGK, (01)00884838067585(21)037CHG, (01)00884838067585(21)03G0BB, (01)00884838067585(21)02WH6F, (01)00884838067585(21)02QK2L, (01)00884838067585(21)037F68, (01)00884838067585(21)0344C9, (01)00884838067585(21)037HLM, (01)00884838067646(21)035R8K, (01)00884838067585(21)02JJ0T, (01)00884838067585(21)031LC8, (01)00884838067585(21)039JWQ, (01)00884838067585(21)03436F, (01)00884838067585(21)039PCB, (01)00884838067585(21)02P8GV, (01)00884838067585(21)B07FFB, (01)00884838067585(21)03F770, (01)00884838067585(21)0319LX, (01)00884838067585(21)02DG0D, (01)00884838067585(21)B0JF93, (01)00884838067585(21)03C7Q0,... [TRUNCATED] |
| Postal code | 17084-8603 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 75 units |
| Reason for recall | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20250905 |
| Initial firm notification | Letter |
| Center classification date | 20260324 |
Overview
- Recalling FirmPhilips Ultrasound, Inc
- StatusOngoing
- Risk LevelClass III
- DistributionUS Nationwide distribution.