Company: Philips Ultrasound, Inc..
Date of Enforcement Report: 5/13/2015
Class lI:

PRODUCT

EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591 (1.2.2) 453561785101 (1.3) 453561800601 (1.3.1) 453561805211 (1.3.2)
Recall Number Z-1579-2015

REASON
When Epiq 7 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients Body Surface Area (BSA).

RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA on 4/10/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
2472 units total

DISTRIBUTION
Nationwide and Internationally

___________________________________