Philips EPIQ Ultrasound Systems — Class II medical device recall Z-1007-2026
Completed recall by Philips Ultrasound, LLC, reported 2026-01-07, distributed nationwide. Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
| Recall number | Z-1007-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, LLC, Bothell, WA, United States |
| Recall initiated | 2022-07-14 |
| Classified | 2025-12-31 |
| Reported by FDA | 2026-01-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, CA, CH, CL, CO, CZ, DE, DK, EC, EE, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IQ, IR, IT, JP, KR, LT, LV, MA, NL, NZ, OM, PA, PH, PL, RO, RS, SA, SE, SI, SK, TH, TR, ZA |
| Quantity | 1,721 systems |
| UPC / GTIN / UDI-DI | 00884838047693, 00884838097933, 00884838107441, 00884838107533, 00884838107540 |
| Model numbers | 795117, 795122, 795200, 795201, 795231, 795232, 795234 |
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 for recall
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1007-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.