FDA-Device2020-02-26Class II
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
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-1271-2020More Philips North America LLC recalls
- FDA-Device2026-07-01Philips Avalon FM20 Fetal Monitor recalled for speaker connector assembly defect
- FDA-Device2026-07-01Philips Avalon Fetal Monitor FM 30 recalled for speaker connector assembly defect
- FDA-Device2026-07-01Philips Telemetry Monitor 5500 recalled for potential device reset and loss of central monitoring connection
- FDA-Device2026-06-17Philips DigitalDiagnost C90 Flex/Value/Chest/ER recalled for missing seismic stabilization kit
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