FDA Device recall Z-2353-2025
C5-2 Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of C5-2 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-2353-2025 |
| 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
C5-2 Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605358813, 989605371711, 989605371713, 989605386651, 989605387521, 989605389241, 989605389242, 98960539821…Model No. 989605358813, 989605371711, 989605371713, 989605386651, 989605387521, 989605389241, 989605389242, 989605398211, 989605399561, 989605418972, 989605430242, 989605451181, 989605454101, 989803002675; UDI: Unique Device Identifier (UDI), (01)00884838067424(21)B200XV, (01)00884838067424(21)B2W963, (01)00884838067424(21)B2XQ5R, (01)00884838067424(21)B31MDB, (01)00884838067424(21)B2BBY9, (01)00884838067424(21)B2C5FJ, (01)00884838067424(21)B329WV, (01)00884838067424(21)B3CWGT, (01)00884838067424, (01)00884838067424(21)F05G0L, (01)00884838061385(21)B1PKRD, (01)00884838067424(21)B224J4, (01)00884838067424(21)B224J7, (01)00884838067424(21)B224JX, (01)00884838067424(21)B224JZ, (01)00884838067424(21)B224MQ, (01)00884838067424(21)B2M756, (01)00884838067424(21)B2M75Q, (01)00884838067424(21)B2M776, (01)00884838067424(21)B34T1T, (01)00884838067424(21)B35Y9P, (01)00884838067424(21)B36LTF, (01)00884838068018(21)B24HQ5, (01)00884838067424(21)F07YGL, (01)00884838067424(21)B2HNC4, (01)0088483806794 |
|---|
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-2353-2025%22
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