FDA DevicesClass III
Philips L12-5 Ultrasound Transducer
Published: April 1, 2026Recall ID: Z-1620-2026Category: 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 L12-5 Ultrasound Transducer
Additional Source Details
| Field | Value |
|---|---|
| City | Reedsville |
| State | PA |
| Event id | 97643 |
| Address 1 | 1 Echo Dr |
| Code info | Model No. 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231; UDI: (01)00884838067851(21)B27H7T, (01)00884838067974(21)B0B0B1, (01)00884838067851(21)B16RRG, (01)00884838067974(21)B0HWBM, (01)00884838067974(21)B0B39M, (01)00884838067851(21)B1N2FG, (01)00884838067851(21)B1DD6B, (01)00884838067851(21)B27GVB, (01)00884838067851(21)B27RQ7, (01)00884838067851(21)B1WT18, (01)00884838067851(21)B1N1JB; Serial No. B107H4, B106RJ, B02RKJ, B0PXC9, B03JZF, B107JF, B27H7T, B0B0B1, B106XL, B10CF6, B14HHX, B10BZF, B04PTM, B16RRG, 0392R5, B1JPC9, B1JQ8W, B0HWBM, B0B39M, B0XK56, B16L5T, B10BQ3, B0J9Q6, B106DF, B105C1, B1N2FG, B10CTM, B01QKF, B10C67, B0FD7B, B0M21H, B0P7ZP, B1DD6B, B0F6F2, B27GVB, B27RQ7, B14CBD, B14J0X, B1WT18, B1N1JB. |
| Postal code | 17084-8603 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 40 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.