Philips Medical Systems North America Co. Phillips

FDA Regulatory Profile

Philips Medical Systems North America Co. Phillips appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0643-2013, Class II) was initiated on July 26, 2012.

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