Company: Philips Ultrasound, Inc..
Date of Enforcement Report: 5/27/2015
Class lI:
PRODUCT
EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591 (1.2.2) 453561785101 (1.3) 453561800601 (1.3.1) 453561805211 (1.3.2) Diagnostic ultrasound imaging and fluid flow analysis
Recall Number Z-1632-2015
REASON
When EPIQ 7 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to “Metric” and weight and/or height is entered, a unit conversion error may result in the incorrect display of their values and incorrect calculation of the patients Body Surface Area (BSA).
RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA on 4/14/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1692 units total (902 units in the US and 790 units outside the US
DISTRIBUTION
Nationwide and Internationally
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