AGFA Healthcare Corp. - April 11, 2014
Issue Date
Apr 11, 2014
Region
Southeast
Category
Device
$117.00
Contact Name
Phil Cuscuna
Contact Title
Director QARA Americas
Address 1
10 S. Academy St.
City
Greenville
State
SC
Zip/Postal Code
29601-2632
Country
United States
Inspection Range
Mar 03, 2014 - Apr 11, 2014
Pages
6
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Claudette D. Brooks