FDA Device recall Z-2061-2025
Philips S8-3t Transducer
- FDA Device
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of Philips S8-3t Transducer by Philips Ultrasound, citing ultrasound transducer devices were refurbished beyond their useful life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2061-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-28 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
Philips S8-3t Transducer.
Reason
Ultrasound transducer devices were refurbished beyond their useful life.
Identifiers
| code_info | Model No. 989605420183, 989605431171, 989605439232, 989605406772, 989605439231, 989606708921, 989803002661; UDI: (01)00…Model No. 989605420183, 989605431171, 989605439232, 989605406772, 989605439231, 989606708921, 989803002661; UDI: (01)00884838073524(21)B2HWZ5, (01)00884838073524(21)B34PCJ, (01)00884838073524(21)B34PBW, (01)00884838073524(21)B37JHN, (01)00884838073524(21)B34P9K, (01)00884838073524(21)B2106G, (01)00884838073524(21)B210DC, (01)00884838073524(21)B2101L, (01)00884838073524(21)B2HX89, (01)00884838073524(21)B2HX1G, (01)00884838073524(21)B2HX7N, (01)00884838073524(21)B2HXBB, (01)00884838073524(21)B2HWZ6, (01)00884838073524(21)B2HXB8, (01)00884838073524(21)B2HX1D, (01)00884838073524(21)B2HWXV, (01)00884838073524(21)B209LJ, (01)00884838073524(21)B37JHP, (01)00884838073524(21)B2HWXW, (01)00884838073524(21)B2105P, (01)00884838073524(21)B1Z0Z8, (01)00884838073524(21)B210D8, (01)00884838073524(21)B21004, (01)00884838073524(21)B1Z0ZD, (01)00884838073524(21)B2HXDN, (01)00884838067523(21)B0XTVJ, (01)00884838073524(21)B2HWXX, (01)00884838073524(21)B20ZYV, (01)00884838073524(21)B2HWWW, (01)0088483807352 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2061-2025%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.