Company:Philips Medical Systems North America Inc.
Date of Enforcement Report: 11/27/2013
Class lI:
PRODUCT
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Recall Number Z-0368-2014
REASON
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)..
RECALLING FIRM/MANUFACTURER
Philips Medical Systems North America Inc., Bothell WA on 10/17/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
284 units total (183 international; 100 in the US).
DISTRIBUTION
Nationwide and Internationally
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