EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analys
FDA device recall Z-0368-2014 · posted 2013-11-20 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Inc.
- 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).
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 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, Franc
- Date initiated
- 2013-10-17
- Date posted
- 2013-11-20
- Date terminated
- 2014-07-16
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EPIQ DIAGNOSTIC ULTRASOUND SYSTEM (K132304) | Philips Ultrasound, Inc. | 2013-08-21 |