FDA Device recall Z-2408-2025
X5-1 Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of X5-1 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-2408-2025 |
| 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
X5-1 Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605400802, 989605438491, 989605353783, 989605427811, 989605353781, 989605412052, 989605455171, 98960543153…Model No. 989605400802, 989605438491, 989605353783, 989605427811, 989605353781, 989605412052, 989605455171, 989605431531, 989605412062, 989605466031, 989605409562, 989605414122, 989605412082; UDI: (01)00884838061422(21)B23Y3N, (01)00884838061422(21)B27BYD, (01)00884838061422(21)B2FCRL, (01)00884838061422(21)B32F76, (01)00884838061422(21)B3MTPX, N/A, (01)00884838061422(21)B29NQ7, (01)00884838061422(21)B3214W, (01)00884838061422(21)B3GYYT, (01)00884838061774(21)B1VBR6, N/A, (01)00884838061422(21)B2W4GN, (01)00884838061422(21)F04ZXB, (01)00884838061422(21)F0F732, (01)00884838061774(21)F01CVG, N/A, (01)00884838061422(21)B2F0M1, (01)00884838061422(21)B2MGRL, (01)00884838061422(21)B320V9, (01)00884838061422(21)B3LQXV, (01)00884838061422(21)F04W88, (01)00884838061422(21)F09L1M, (01)00884838061422(21)B3P1B2, (01)00884838061422(21)F0D14W, (01)00884838061422(21)B268JG, (01)00884838061422(21)B27YP4, (01)00884838061422(21)B2XBW5, (01)00884838061422(21)B320LD, (01)00884838061422(21)B3GZ6M, (01)0088 |
|---|
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-2408-2025%22
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