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Philips North America LLC recalls Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Recalled February 26, 2020 · FDA recall Z-1271-2020 · Philips North America
Hazard
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards. · FDA Class II
Units
44 units
Sold at
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
Description
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Product
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Manufacturer(s)
Philips North America LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →