FDA Device recall Z-2413-2025
X8-2t Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of X8-2t 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-2413-2025 |
| 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
X8-2t Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605455171, 989605400802, 989605409562, 989605414122; UDI: (01)00884838069718(21)B2DKRP, (01)00884838069718…Model No. 989605455171, 989605400802, 989605409562, 989605414122; UDI: (01)00884838069718(21)B2DKRP, (01)00884838069718(21)B2XD88, (01)00884838069718(21)B3DRBX, (01)00884838069718(21)B3DRF0, (01)00884838069718(21)B3DRGX, (01)00884838069718(21)F0GWCW, (01)00884838069718(21)B277WX, (01)00884838069718(21)F04WX2, (01)00884838069718(21)F0B4PV, (01)00884838069718(21)B2VQJ5, (01)00884838069718(21)F010V3, (01)00884838069718(21)F042C2, (01)00884838069718(21)F06TQ3, (01)00884838069718(21)F086C1, (01)00884838069718(21)F086C2, (01)00884838069718(21)F08835, (01)00884838069718(21)F09BV3, (01)00884838069718(21)F0DK0W, (01)00884838069718(21)F0FDNF, (01)00884838069718(21)F0K1TQ, (01)00884838069718(21)F0K5JZ, (01)00884838069718(21)F0186H, (01)00884838069718(21)F03RVN, (01)00884838069718(21)F052P3, (01)00884838069718(21)F05445, (01)00884838069718(21)F0BRLQ, (01)00884838069718(21)F0D1XZ, (01)00884838069718(21)B2JHG3, (01)00884838069718(21)B39B92, (01)00884838069718(21)F0LW0Y, (01)00884838069718(21)F0LW10, |
|---|
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-2413-2025%22
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