FDA Device recall Z-2363-2025
C9-4 Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of C9-4 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-2363-2025 |
| 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
C9-4 Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605365021, 989605365023, 989605387291; UDI: (01)00884838064607(21)B1FZ1B, (01)00884838064607(21)B2KL13, (0…Model No. 989605365021, 989605365023, 989605387291; UDI: (01)00884838064607(21)B1FZ1B, (01)00884838064607(21)B2KL13, (01)00884838064607(21)B30GDB, (01)00884838064607(21)B33HMW, (01)00884838064607(21)B3CL5L, (01)00884838064607(21)B1VKTB, (01)00884838064607(21)B2KL31, (01)00884838064607(21)B2JZ44, (01)00884838064607(21)B3GX1T, (01)00884838064607(21)B1XRF3, (01)00884838064607(21)B34QB8, (01)00884838064607(21)B1GFMQ, (01)00884838064607(21)B1RYG9, (01)00884838064607(21)B23TC6, (01)00884838064607(21)B1XRF1, (01)00884838064607(21)B1XN5J, (01)00884838064607(21)B1RYG6, (01)00884838064607(21)B2JTTX, (01)00884838064607(21)B3DLZ0, (01)00884838064607(21)B33XZB, (01)00884838064607(21)B1NPG7, (01)00884838064607(21)B1VJYF, (01)00884838064607(21)B3H0QV, (01)00884838064607(21)B3LNZH, (01)00884838064607(21)B31DH7, (01)00884838064607(21)B1RVCQ, (01)00884838064607(21)B34VJ7, (01)00884838064607(21)B3DC5D, (01)00884838064607(21)B1RYL2, (01)00884838064607(21)B1RVCR, (01)00884838064607(21)B1RYN1, (01)008848380 |
|---|
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-2363-2025%22
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