FDA Device recall Z-2349-2025
BP10-5ec Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of BP10-5ec 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-2349-2025 |
| 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
BP10-5ec Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605395642; UDI: (01)00884838061552(21)B29VPV, (01)00884838061552(21)B29VQ6, (01)00884838061552(21)B2CYJ4,…Model No. 989605395642; UDI: (01)00884838061552(21)B29VPV, (01)00884838061552(21)B29VQ6, (01)00884838061552(21)B2CYJ4, (01)00884838061552(21)F06M63, (01)00884838061552(21)F06QYR, (01)00884838061552(21)B2CY7P, (01)00884838061552(21)F058R4, (01)00884838061552(21)B2CY8T, (01)00884838061552(21)F05YF6, (01)00884838061552(21)F0628C, (01)00884838061552(21)B29VPW, (01)00884838061552(21)F064N9, (01)00884838061552(21)F078HF, (01)00884838061552(21)F05Y6Y, (01)00884838061552(21)B2CYJJ, (01)00884838061552(21)B2CYD7; Serial No. B29VPV, B29VQ6, B2CYJ4, F06M63, F06QYR, B2CY7P, F058R4, B2CY8T, F05YF6, F0628C, B29VPW, F064N9, F078HF, F05Y6Y, B2CYJJ, B2CYD7. |
|---|
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-2349-2025%22
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