EPIQ 7 Ultrasound System — Class II medical device recall Z-0368-2014
Terminated recall by Philips Medical Systems North America Inc., reported 2013-11-27, distributed nationwide. A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using
| Recall number | Z-0368-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems North America Inc., Bothell, WA, United States |
| Recall initiated | 2013-10-17 |
| Classified | 2013-11-20 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CL, DE, DK, ES, FI, FR, GB, IE, IN, KR, LV, NL, NO, NZ, PL, PT, RO, SA, SE, SK |
| Reason classes | software |
| Model numbers | 795200, 795201, 795202 |
Product
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Reason for recall
A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).
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-0368-2014. 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.