Konica Medical Imaging, Inc. Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.
Brand
Konica Medical Imaging, Inc.
Lot Codes / Batch Numbers
All serial numbers.
Products Sold
All serial numbers.
Konica Medical Imaging, Inc. is recalling Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software. due to One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm contacted all customers of the problem on 4/7/2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026