Philips Ultrasound, Inc. recalls EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPI…

Recall date

April 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1631-2015

FDA classification

Class II

Brand / firm

Philips Ultrasound, Inc.

Sold / distributed

Worldwide Distribution

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.