FDA Device recall Z-1264-2014
Philips Model EPIQ 7 Ultrasound System
- FDA Device
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of Philips Model EPIQ 7 Ultrasound System by Philips Medical Systems North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1264-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-28 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems North America |
| Distribution | US |
Product
Philips Model EPIQ 7 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
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 b
Identifiers
| code_info | All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1264-2014%22
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