Reported Nov 27, 2013 · Terminated
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow…
Philips Medical Systems North America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems North America Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
- Lot codes and dates
- TRACE ITEM
- SERIAL NUMBERS in the UNITED STATES
101 of 101 codes
US713B0171US713B0207US813B0017US813B0018US813B0019US813B0020US813B0022US813B0023US813B0024US813B0025US813B0122US813B0123US813B0125US813B0127US813B0128US813B0129US813B0131US813B0132US813B0134US813B0135US813B0233US813B0234US813B0235US813B0236US813B0237US813B0238US813B0239US813B0240US813B0423US813B0424US813B0425US813B0426US813B0427US813B0428US813B0429US813B0430US813B0431US813B0432US813B0433US813B0434US913B0033US913B0034US913B0035US913B0036US913B0037US913B0038US913B0039US913B0040US913B0057US913B0060US913B0061US913B0062US913B0063US913B0064US913B0065US913B0066US913B0106US913B0107US913B0108US913B0109
- TRACE ITEM SERIAL NUMBERS INTERNATIONAL
206 of 206 codes
US513B0224US513B0295US513B0387US513B0560US613B0299US713B0085US713B0086US713B0118US713B0119US713B0120US713B0122US713B0123US713B0126US713B0149US713B0171US713B0172US713B0192US713B0193US713B0194US713B0195US713B0204US713B0205US713B0206US713B0208US713B0324US713B0325US713B0358US713B0359US713B0437US713B0439US713B0440US713B0532US713B0537US713B0573US713B0574US713B0575US713B0576US713B0577US713B0578US713B0579US713B0580US713B0581US713B0582US713B0583US713B0584US713B0586US713B0587US713B0588US713B0589US713B0590US713B0592US713B0593US713B0594US713B0595US813B0015US813B0016US813B0032US813B0037US813B0038US813B0039
- Amount recalled
- 306 units total (206 international; 100 in the US).
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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