Nov

2013

Cl II Philips EPIQ 7 Ultrasound System

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Philips EPIQ 7 Ultrasound System

Amy Sellers

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