FDA Device recall Z-2406-2025
X11-4t Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of X11-4t 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-2406-2025 |
| 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
X11-4t Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605501821; UDI: (01)00884838102729(21)F0JZ1H, (01)00884838102729(21)F0KDBZ, (01)00884838102729(21)F0KL95,…Model No. 989605501821; UDI: (01)00884838102729(21)F0JZ1H, (01)00884838102729(21)F0KDBZ, (01)00884838102729(21)F0KL95, (01)00884838102729(21)F0KDC4, (01)00884838102729(21)F0GF3C, (01)00884838102729(21)F0JX4T, (01)00884838102729(21)F0JW38, (01)00884838102729(21)F0JX4N, (01)00884838102729(21)F0JL69, (01)00884838102729(21)F0JW3F, (01)00884838102729(21)F0KL87, (01)00884838102729(21)F0JTZB, (01)00884838102729(21)F0K1V3, (01)00884838102729(21)F0JY4F, (01)00884838102729(21)F0K5PZ, (01)00884838102729(21)F0KRDC, (01)00884838102729(21)F0K5Q0, (01)00884838102729(21)F0K5LG, (01)00884838102729(21)F0KL8H, (01)00884838102729(21)F0JL67, (01)00884838102729(21)F0GXQV, (01)00884838102729(21)F0GZ3K, (01)00884838102729(21)F0GXQ7, (01)00884838102729(21)F0JMYN, (01)00884838102729(21)F0JTZD, (01)00884838102729(21)F0K5LX, (01)00884838102729(21)F0JX4M, 010088483810272921F0GLHY, (01)00884838102729(21)F0HCC8, (01)00884838102729(21)F0JZ1Y, (01)00884838102729(21)F0KL8R, (01)00884838102729(21)F0GZ2V, (01)00884838102 |
|---|
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-2406-2025%22
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