Philips Model EPIQ 5 Ultrasound System — Class II medical device recall Z-1263-2014
Terminated recall by Philips Medical Systems North America Inc., reported 2014-03-26, distributed nationwide. A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrec
| Recall number | Z-1263-2014 |
|---|---|
| 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 | 2014-02-28 |
| Classified | 2014-03-20 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2016-12-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, EC, EG, ES, FI, FR, GB, GR, IE, IN, IT, JP, KR, MY, NL, NO, NZ, PE, PH, PT, SA, SE, SG, TH, TR, ZA |
| Model numbers | 795200, 795201, 795202, 795204, 795205, 795206 |
Product
Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.
Reason for recall
A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by
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-1263-2014. 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.