Merge Healthcare, Inc. - July 27, 2015
Issue Date
Jul 27, 2015
Region
Central
Category
Device
$117.00
Contact Name
Michael J. Diedrick
Contact Title
V.P. Quality Division/Site Management Representative
Address 1
900 Walnut Ridge Dr.
City
Hartland
State
WI
Zip/Postal Code
53029-8347
Country
United States
Inspection Range
Jun 03, 2015 - Jul 27, 2015
Pages
6
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Richard Jay Tucker