Philips Ultrasound, Inc. - 12/9/2011
Issue Date
Dec 09, 2011
Region
Pacific
Category
Device
$117.00
Address 1
22100 Bothell-Everett Hwy.
City
Bothell
State
WA
Zip/Postal Code
98041-3003
Country
United States
Inspection Range
Dec 05, 2011 - Dec 09, 2011
Pages
3
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): James R. Fleckenstein and Graham N. Giesen