Philips Medical Systems North America Co. Phillips

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0643-2013Class IIPhilips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and July 26, 2012
Z-0642-2013Class IIPhilips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical SysteJuly 26, 2012