Konica Minolta Medical Imaging USA, Inc. REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction.
Brand
Konica Minolta Medical Imaging USA, Inc.
Lot Codes / Batch Numbers
58 units distributed between June 2003 and January 2006. Software version prior to January 31, 2006.
Products Sold
58 units distributed between June 2003 and January 2006. Software version prior to January 31, 2006.
Konica Minolta Medical Imaging USA, Inc. is recalling REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality due to If the patient demographic data is entered into the CS-1 manually, and the user fails to enter any data in one of the demographic data fields labeled . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If the patient demographic data is entered into the CS-1 manually, and the user fails to enter any data in one of the demographic data fields labeled as Birthday, Sex, Name or Patient Comments, etc, the RIM will populate the fields where no data has been entered with data from the previous patient.
Recommended Action
Per FDA guidance
The firm phoned the customers on 2/6/2006 to inform them of the recall and the corrective action associated to the recall. This will be followed up with a fax, e-mail and letter. The final step will be visiting the location to install the correct software.
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