Company: Philips Ultrasound, Inc..
Date of Enforcement Report: 5/27/2015
Class lI:
PRODUCT
EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1) 453561805181 (1.3.2) Diagnostic ultrasound imaging and fluid flow analysis.
Recall Number Z-1631-2015
REASON
When EPIQ 5 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
Total 1108 units (490 units in US and 618 units outside the US)
DISTRIBUTION
Nationwide and Internationally
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