FDA DevicesClass III
Philips Mini Multi TEE Ultrasound Transducer
Published: April 1, 2026Recall ID: Z-1622-2026Category: 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 Mini Multi TEE Ultrasound Transducer
Additional Source Details
| Field | Value |
|---|---|
| City | Reedsville |
| State | PA |
| Event id | 97643 |
| Address 1 | 1 Echo Dr |
| Code info | Model No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M. |
| Postal code | 17084-8603 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 11 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.