FDA Medical Device Recalls (openFDA)
Konica Medical Imaging, Inc.: Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.
- Recall number
- Z-1391-05
- Recalling firm
- Konica Medical Imaging, Inc.
- Product
- Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.
- Status
- Terminated
- Initiated
- 2005-03-30
- Posted
- 2005-08-13
- Terminated
- 2005-08-31
- Reason
- 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.
- Root cause
- Other
- Action
- The firm contacted all customers of the problem on 4/7/2005.
- Quantity
- 60
- Distribution
- These units have been distributed to hospitals and clinics nationwide.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LMA
- Firm FEI
- 2241281
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28