666779

Philips Medical Systems (Cleveland) Inc — FEI 1525965

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 14, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Cleveland, OH (United States)

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
73121 CFR 803.50(a)(1)Report of Death or Serious Injury
73221 CFR 803.50(a)(2)Individual Report of Malfunction