FDA Device recall Z-1628-2026
Philips X7-2 Ultrasound Transducer
- FDA Device
- Class III
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class III recall of Philips X7-2 Ultrasound Transducer 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-1628-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-09-05 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
Philips X7-2 Ultrasound Transducer
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605388121, 989605347571, 989605347573; UDI: (01)00884838061729(21)0344RZ; Serial No. 03FG1T, 031LM2, 032Q7G, 0344RZ, 033VM9. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1628-2026%22
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