FDA Device recall Z-2409-2025
X5-1c Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of X5-1c 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-2409-2025 |
| 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
X5-1c Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989606702251, 989605455171, 989605400802, 989605412042; UDI: (01)00884838093843(21)F0B2Q1, 010088483809384321…Model No. 989606702251, 989605455171, 989605400802, 989605412042; UDI: (01)00884838093843(21)F0B2Q1, 010088483809384321F0GQ0H, (01)00884838093843(21)F0CD0N, (01)00884838093843(21)F0C1LB, (01)00884838093843(21)F03QX3, (01)00884838093843(21)F04HV1, (01)00884838093843(21)F0851Z, (01)00884838093843(21)F0BY6P, (01)00884838093843(21)F0FJPN, (01)00884838093843(21)F0GGZX, (01)00884838093843(21)F0JYX2, (01)00884838093843(21)F0J1ZT, (01)00884838093843(21)F0J3KH, (01)00884838093843(21)F0J3MD, (01)00884838093843(21)F0J52B, (01)00884838093843(21)F0J5TY, 010088483809384321F0GFC3, (01)00884838093843(21)F0LYRP, (01)00884838093843(21)F0LYRR, (01)00884838093843(21)F0DGGR, (01)00884838093843(21)F06Z9C, (01)00884838093843(21)F0C1NV, (01)00884838093843(21)F0GXM7, (01)00884838093843(21)F0JJPV, (01)00884838093843(21)F0L50Z, (01)00884838093843(21)F0L5CW, (01)00884838093843(21)F0LX6M, (01)00884838093843(21)F0M0H8, (01)00884838093843(21)F0CBZ7, (01)00884838093843(21)F0HXLR, (01)00884838093843(21)F0DC7Q, (01)008 |
|---|
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-2409-2025%22
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