FDA-Device2020-02-26Class II
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Philips North America LLC
Hazard
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Sold states
HeartStart FRx: US - CA, CT, FL, IL, MO, NY,TN, TX and WI OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan. HeartStart HS1: US - CT, FL, IL, MI, MS, NJ, TN, TX, WA and WI OUS - Argentina, Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, Spain, Sweden, and Taiwan
Affected count
44 units
Manufactured in
22100 Bothell Everett Hwy, Bothell, WA, United States
Products
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1271-2020Don't want to check this manually?
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