Atlas FDA

Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.

FDA device recall Z-1391-05 · posted 2005-08-13 · Terminated

Recall details

Recalling firm
Konica Medical Imaging, Inc.
Reason for recall
One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.
Action taken
The firm contacted all customers of the problem on 4/7/2005.
Root cause
Other
Status
Terminated
Product code
LMA
Quantity affected
60
Distribution
These units have been distributed to hospitals and clinics nationwide.
Date initiated
2005-03-30
Date posted
2005-08-13
Date terminated
2005-08-31
Location
Wayne, NJ

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