Mobius Imaging, LLC - April 4, 2018
Issue Date
Apr 04, 2018
Region
Northeast
Category
Device
$117.00
Contact Name
Eugene Alma Gregerson
Contact Title
President and CEO
Address 1
2 Shaker Rd.
Address 2
Ste. F100
City
Shirley
State
MA
Zip/Postal Code
01464-2535
Country
United States
Inspection Range
Apr 02, 2018 - Apr 04, 2018
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): John A. Sciacchitano