FDA Device recall Z-2410-2025
X6-1 Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of X6-1 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-2410-2025 |
| 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
X6-1 Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605409282, 989605438511, 989605357141, 989605357143, 989605427801; UDI: (01)00884838061446(21)B22RP6, (01)…Model No. 989605409282, 989605438511, 989605357141, 989605357143, 989605427801; UDI: (01)00884838061446(21)B22RP6, (01)00884838061446(21)F01N54, (01)00884838061446(21)B28KXP, (01)00884838061446(21)B2HRV1, (01)00884838061446(21)F0HR2C, (01)00884838061446(21)B2K24P, (01)00884838061446(21)B2L7JQ, (01)00884838061446(21)B3D77Q, (01)00884838061446(21)F02MHJ, (01)00884838061446(21)B21DYX, (01)00884838061781(21)B1Z20M, (01)00884838061781(21)B22QTZ, (01)00884838061781(21)B26888, (01)00884838061781(21)B28KXF, (01)00884838061446(21)B29X6N, (01)00884838061446(21)B37K59, (01)00884838061446(21)B2F0XT, (01)00884838061781(21)B305VR, (01)00884838061781(21)B3BPQL, (01)00884838061446(21)F0CFRQ, (01)00884838061446(21)B2L8ZT, (01)00884838061446(21)B1JBW3, (01)00884838061446(21)B1JD06, (01)00884838061446(21)B1JFHH, (01)00884838061446(21)F00PZJ, (01)00884838061446(21)B29Y6B, (01)00884838061446(21)B2RWK0, (01)00884838061446(21)B305W1, (01)00884838061446(21)B1JCTV, (01)00884838061446(21)F04123, (01)00884838061 |
|---|
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-2410-2025%22
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