Recall Z-1264-2014— Philips Medical Systems North America Inc.

Name: FDA recall Z-1264-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-28

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems North America Inc., initiated 2014-02-28, terminated 2016-12-12. It names one FDA 510(k) clearance: K132304. 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.

Recalling firm: Philips Medical Systems North America Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-28
Terminated: 2016-12-12
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K132304 — EPIQ DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc.·cleared 2013-08-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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 b

Data sourced from openFDA. This site is unofficial and independent of the FDA.