GE Healthcare Beijing, Hangwei Medical Systems, Co. Ltd - 9/1/2011
Issue Date
Sep 01, 2011
Region
Central
Category
Device
$117.00
Address 1
No. 2 Yong Chang Rd. Beijing Econ. & Tech. Dev. Zone
City
Beijing
Zip/Postal Code
100176
Country
China
Inspection Range
Aug 29, 2011 - Sep 01, 2011
Pages
2
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): Donna L. Tartaglino Besone