FDA Device recall Z-1620-2026
Philips L12-5 Ultrasound Transducer
- FDA Device
- Class III
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class III recall of Philips L12-5 Ultrasound Transducer by Philips Ultrasound, citing to provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1620-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-09-05 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
Philips L12-5 Ultrasound Transducer
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231; UDI: (01)00884838067851(2…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Philips Ultrasound
- Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
FDA Device · Class II · 2026-09-30 · Philips Ultrasound - Philips C9-4 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips X7-2 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips L17-5 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips OMNI III TEE Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound
All Philips Ultrasound recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1620-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.