Philips Medical Systems (Cleveland), Inc. - Dec. 3, 2010
Issue Date
Dec 03, 2010
Region
Central
Category
Device
$117.00
Contact Name
Jonathan J. Mazelsky
Contact Title
Senior VP and GM of CT and NM
Address 1
595 Miner Rd.
City
Cleveland
State
OH
Zip/Postal Code
44143-2131
Country
United States
Inspection Range
Aug 25, 2010 - Dec 03, 2010
Pages
13
First Observation
A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiation the correction or removal.
Investigator(s): Benjamin J. Dastoli and Edward R. Kay