FDA Device recall Z-2395-2025
S7-3t Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of S7-3t 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-2395-2025 |
| 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
S7-3t Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605406772, 989605439232, 21781A, 989606708921, 989605406771, 989605414122; UDI: (01)00884838061439(21)B210…Model No. 989605406772, 989605439232, 21781A, 989606708921, 989605406771, 989605414122; UDI: (01)00884838061439(21)B21003, (01)00884838061439(21)B3DV68, (01)00884838061439(21)F09Q11, (01)00884838061439(21)B2HXGF, (01)00884838061439(21)F0FJZW, (01)00884838061439(21)F01L0D, (01)00884838061439(21)F02LYB, (01)00884838061439(21)B3JQNC, (01)00884838061439(21)B3JQND, (01)00884838067530(21)B1TDDC, (01)00884838067530(21)B1V2XQ, (01)00884838067530(21)B2HX6Y, N/A, (01)00884838061439(21)F0DZC5, (01)00884838061439(21)B2HXKB, (01)00884838061439(21)B2HXKJ, (01)00884838061439(21)B2HXL1, (01)00884838061439(21)B2HXL4, (01)00884838061439(21)B30FDR, (01)00884838061439(21)B30FDW, (01)00884838061439(21)B30FHX, (01)00884838061439(21)B3DV36, (01)00884838061439(21)F068H7, (01)00884838061439(21)B2HWXC, (01)00884838061439(21)B3JQNB, (01)00884838061439(21)F032XF, N/A, (01)00884838061439(21)B30FFN, (01)00884838061439(21)B3DVDD, 010088483806143921F0GH3M, (01)00884838061439(21)B1X57T, (01)00884838061439(21)B2HWZL, ( |
|---|
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-2395-2025%22
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