FDA Device recall Z-2397-2025
S8-3 Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of S8-3 Transducer Probe 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-2397-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-07-03 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
S8-3 Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605361882, 989605440752, 989605361963, 989605438401, 989605387401, 989605387421, 989605400802, 98960536196…Model No. 989605361882, 989605440752, 989605361963, 989605438401, 989605387401, 989605387421, 989605400802, 989605361961, 989605361881, 989605362004, 989605362002, 21750A, 989605362003, 989605440682; UDI: (01)00884838067806(21)B2D78M, (01)00884838067806(21)B2PXNB, (01)00884838067806(21)B2TFQK, (01)00884838067806(21)B2TFQL, (01)00884838067806(21)B2TGWJ, (01)00884838067806(21)B2TGWP, (01)00884838067806(21)B3FQQB, (01)00884838067806(21)B3LC7N, (01)00884838067622(21)B3KM0K, (01)00884838067929(21)B20KQ4, (01)00884838067806(21)B2PXHR, (01)00884838067806(21)B20GMQ, (01)00884838067806(21)B2H3T2, (01)00884838067806(21)B20H2W, (01)00884838067806(21)F09M9D, (01)00884838067806(21)B3LGXW, (01)00884838067806(21)B2DF83, (01)00884838067806(21)B2PXW5, (01)00884838067806(21)F070MP, (01)00884838067806(21)F0J1R9, (01)00884838067806(21)B1MWN1, (01)00884838067806(21)B1MWQ5, (01)00884838067806(21)B27J9L, 010088483806780621F0FGBV, N/A, (01)00884838067806(21)B2D8JJ, (01)00884838067929(21)B24R5L, (01)0088483806 |
|---|
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-2397-2025%22
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