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.
FDA Recall Z-0862-06 · Posted 2006-05-16
Recalling FirmKonica Minolta Medical Imaging USA, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-02-06
Date Terminated2008-08-22
Product Quantity58 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
The units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.