FDA DevicesClass III
Philips X3-1 Ultrasound Transducer
Published: April 1, 2026Recall ID: Z-1627-2026Category: 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 X3-1 Ultrasound Transducer
Additional Source Details
| Field | Value |
|---|---|
| City | Reedsville |
| State | PA |
| Event id | 97643 |
| Address 1 | 1 Echo Dr |
| Code info | Model No. 989605440742, 989603002321, 989605388101, 989605440741; UDI: (01)00884838067615(21)033TVZ, (01)00884838067615(21)02Q8R3, (01)00884838067615(21)02VLZV, (01)00884838067615(21)02WND0, (01)00884838067615(21)02ZWBH, (01)00884838067615(21)02GP3C, (01)00884838067615(21)03DTL6, (01)00884838067615(21)02JK1H, (01)00884838067615(21)02VMJ6, (01)00884838067615(21)035Z89, (01)00884838067615(21)031C21, (01)00884838067615(21)02JL3W, (01)00884838067615(21)03C066, (01)00884838067615(21)02JK8D; Serial No. 033TVZ, 02Q8R3, 02VLZV, 02WND0, 02ZWBH, 02GP3C, 02YHTG, 02YHPN, 03DTL6, 02JK1H, 02VMJ6, 035Z89, 031C21, 038NQC, 02JL3W, 03C066, 02JK8D. |
| Postal code | 17084-8603 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 17 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.