FDA-Device2021-10-20Class II
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Hazard
Customers were not notified of previous recalls associated with various defibrillator models.
Sold states
U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.
Affected count
15 units
Manufactured in
22100 Bothell Everett Hwy, N/A, Bothell, WA, United States
Products
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0081-2022More 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 Part numberM2703A
- FDA-Device2026-07-01Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
- FDA-Device2026-06-17Philips DigitalDiagnost C90 Flex/Value/Chest/ER recalled for missing seismic stabilization kit
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