FDA Device recall Z-2358-2025
C8-4v Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of C8-4v 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-2358-2025 |
| 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
C8-4v Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989803002685, 989605416131, 989605408153, 989605430232, 989605416141, 989605364943, 989605388111, 98960538726…Model No. 989803002685, 989605416131, 989605408153, 989605430232, 989605416141, 989605364943, 989605388111, 989605387261, 989605408151, 989605361973, 989605408141, 989605430242, 989605364941; UDI: Unique Device Identifier (UDI), (01)00884838067745(21)B1YRNV, (01)00884838067981(21)B35BZF, (01)00884838067981(21)B24PBY, (01)00884838067981(21)B27T4Z, (01)00884838067981(21)B35H6L, (01)00884838067981(21)B1RPRM, (01)00884838068032(21)B2DGF2, (01)00884838067981(21)B1MZ1D, (01)00884838067981(21)B1X19N, (01)00884838067981(21)B1MYCZ, (01)00884838067981(21)B1RKT8, (01)00884838067981(21)B3PYXD, (01)00884838067981(21)B2TL3C, (01)00884838067981(21)B20NKJ, (01)00884838068032(21)B1X2X3, (01)00884838068032(21)B2TN85, (01)00884838068032(21)B2TTB8, (01)00884838068032(21)B2ZHBM, (01)00884838068032(21)B2ZHDD, (01)00884838067981(21)B2TKV5, (01)00884838067981(21)B40GX1, (01)00884838068032(21)B1RRJL, (01)00884838067981(21)B3ZCR0, (01)00884838067981(21)F09JPD, (01)00884838067981(21)B20G80, (01)00884838067981(21 |
|---|
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-2358-2025%22
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