Z-1391-05

Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software

Name: Z-1391-05 Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software
Creator: Konica Medical Imaging, Inc.
Published: 2005-03-30
License: https://open.fda.gov/license/

Konica Minolta, Inc. / initiated 2005-03-30 / Terminated / root cause: software

FDA source

Konica Medical Imaging, Inc. began a recall of Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software on 2005-03-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1391-05
Status: Terminated
Initiated: 2005-03-30
Posted: 2005-08-13
Terminated: 2005-08-31
Recalling firm: Konica Minolta, Inc.
Product: Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.
Product code: LMA Digitizer, Image, Radiological
Reason for recall: 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 tag: software
FDA root cause: Other
Action: The firm contacted all customers of the problem on 4/7/2005.
Quantity in commerce: 60
Distribution: These units have been distributed to hospitals and clinics nationwide.
Product codes and lots: All serial numbers.

Product code LMA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)