Recall Z-0368-2014 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Medical Systems North America Inc.
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
| Date | Nov 20, 2013 (initiated Oct 17, 2013) |
| Status | Terminated |
| 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). |
| Root cause | Software design |
| Action | Affected customers will be notified via the Urgent-Field Safety Notice (FSN79500286), Philips Model EPIQ 7 Ultrasound system, dated 2013 October. Customers are informed that using the International System Date Format in the Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. may result in calculation errors in Gestational Age and Established Due Date (EDD). Philips will upgrade customer systems to software version 1.1, which corrects the issue, for a free of charge. |
| Quantity | 306 units total (206 international; 100 in the US). |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of CT, HI, IL, IN, KY, MA, ME, MI, NC, OR, PA, TX, and WA, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Ireland, Republic of Korea, Latvia, Netherlands, New Caledonia, New Zealand, Nor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc., Aug 21, 2013 |