FDA Device recall Z-1007-2026
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795…
- FDA Device
- Class II
- completed
- Published 2026-01-07
On 2026-01-07 the FDA classified a Class II recall of Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795… by Philips Ultrasound, citing retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1007-2026 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-07-14 |
| Published | 2026-01-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Reason
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Identifiers
| code_info | Software Version Numbers: 9.0, 9.01, 9.02 795234/UDI: (01)00884838107540 795232/UDI: (01)00884838107533 795231/ UDI: (0…Software Version Numbers: 9.0, 9.01, 9.02 795234/UDI: (01)00884838107540 795232/UDI: (01)00884838107533 795231/ UDI: (01)00884838097933 795201/UDI: (01)00884838047693 795200/ UDI: (01)00884838107441 795122/ UDI: (01)00884838097933 795117/ UDI: (01)00884838047693 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1007-2026%22
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