FDA Device recall Z-2365-2025
C9-5ec Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of C9-5ec 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-2365-2025 |
| 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
C9-5ec Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605387351, 989605440802; UDI: (01)00884838067677(21)B1X88J, (01)00884838067677(21)B264HW, (01)008848380676…Model No. 989605387351, 989605440802; UDI: (01)00884838067677(21)B1X88J, (01)00884838067677(21)B264HW, (01)00884838067677(21)B36JG7, (01)00884838067677(21)B29HQQ, (01)00884838067677(21)B264LH, (01)00884838067677(21)B2X78L, (01)00884838067677(21)B3055N, (01)00884838067677(21)B284J2, (01)00884838067677(21)F06LP2, (01)00884838067677(21)B1K3BP, (01)00884838067677(21)B32262, (01)00884838067677(21)B36JHC, (01)00884838067677(21)B2J631, (01)00884838067677(21)B3224T, (01)00884838067677(21)F02K00, (01)00884838067677(21)B2X710, (01)00884838067677(21)B3MDX4, (01)00884838067677(21)B1LJYQ, (01)00884838067677(21)B36JPK, (01)00884838067677(21)F02R0G, (01)00884838067677(21)B3225C, (01)00884838067677(21)B1M76Q, (01)00884838067677(21)B1X891, (01)00884838067677(21)B1X8BM, (01)00884838067677(21)B1X8CY, (01)00884838067677(21)B1X8FQ, (01)00884838067677(21)B201N5, (01)00884838067677(21)B201N7, (01)00884838067677(21)B29JBL, (01)00884838067677(21)B2X71C, (01)00884838067677(21)B2X7BN, (01)00884838067677(21)B29HT |
|---|
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-2365-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.