Z-0862-06

REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control...

Name: Z-0862-06 REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control...
Creator: Konica Minolta Medical Imaging USA, Inc.
Published: 2006-02-06
License: https://open.fda.gov/license/

Konica Minolta, Inc. / initiated 2006-02-06 / Terminated / root cause: labeling and UDI

FDA source

Konica Minolta Medical Imaging USA, Inc. began a recall of REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded... on 2006-02-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0862-06
Status: Terminated
Initiated: 2006-02-06
Posted: 2006-05-16
Terminated: 2008-08-22
Recalling firm: Konica Minolta, Inc.
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 58 units
Distribution: The units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts.
Product codes and lots: 58 units distributed between June 2003 and January 2006. Software version prior to January 31, 2006.

Product code LLZ

K051523Class IIRegius Console Cs-2000 and Regius Console Cs-3000, Medical Image Processing WorkstationKonica Minolta Medical & Graphic, Inc. / cleared 2005-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)