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1059359

GE Medical Systems Information Technologies, Inc. — FEI 2124823

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 19, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Milwaukee, WI (United States)

Facility

Other inspections at this facility

  • 849871 (VAI Wed Sep 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802525 (VAI Tue Oct 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 679075 (NAI Fri Aug 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
367721 CFR 820.30(g)Design validation - software validation not performed
369621 CFR 820.100(b)Documentation
420221 CFR 806.10(c)(9)Device number, identification
63121 CFR 803.17(a)(1)Lack of System for Event Evaluations