FDA Device recall Z-2394-2025
S5-2 Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of S5-2 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-2394-2025 |
| 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
S5-2 Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605412082, 989605440682, 989605388091, 21314A, 989605438581, 989605361871, 989605412081, 989605961871, 989…Model No. 989605412082, 989605440682, 989605388091, 21314A, 989605438581, 989605361871, 989605412081, 989605961871, 989605391922, 989605387852, 989605440752, 989605412052, 989605361892, 989605384711, 989605400802; UDI: (01)00884838061637(21)B268VV, (01)00884838061637(21)B2BK4Q, (01)00884838061637(21)B2XV6D, (01)00884838061637(21)B2XVMK, (01)00884838061637(21)B3GLNL, (01)00884838061637(21)B3H17V, (01)00884838061637(21)B3H60B, (01)00884838061637(21)B3RBBZ, (01)00884838061637(21)F00X3V, (01)00884838061637(21)F055Z3, (01)00884838061637(21)F07YX6, (01)00884838061637(21)F0DZGY, (01)00884838061637(21)F0H3M1, (01)00884838061637(21)B3NT5N, (01)00884838061637(21)B1WFML, (01)00884838067561(21)B2BJQ4, (01)00884838067561(21)B2BK64, (01)00884838061637(21)B1Q2GH, (01)00884838061637(21)B1QVY3, 010088483806163721F0G049, (01)00884838061637(21)B3DGJ9, (01)00884838061637(21)F02WHD, (01)00884838061637(21)F0CM58, (01)00884838067561(21)B3D85G, (01)00884838067561(21)F0B3B2, (01)00884838061637(21)B1KYB4, (01)0 |
|---|
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-2394-2025%22
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