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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