FDA-Device2015-05-13Class II
EPIQ 5 Ultrasound System with 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)
Philips Ultrasound, Inc.
Hazard
When Epiq 5 Ultrasound System, WITH 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 calculation of the patients Body Surface Area (BSA).
Sold states
Worldwide Distribution - US (nationwide and DC) and Internationally to Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey.
Affected count
751 units total (246 units in the US and 505 units outside the US)
Manufactured in
22100 Bothell Everett Hwy, N/A, Bothell, WA, United States
Products
EPIQ 5 Ultrasound System with 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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1578-2015Don't want to check this manually?
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