Recall Z-0368-2014— Philips Medical Systems North America Inc.

Name: FDA recall Z-0368-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-17

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems North America Inc., initiated 2013-10-17, terminated 2014-07-16. It names one FDA 510(k) clearance: K132304. Product: EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.. 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: Philips Medical Systems North America Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Terminated: 2014-07-16
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

EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.

Reason for recall

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).

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