Recall Z-0862-06 ยท LLZ System, Image Processing, Radiological
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 s
| Date | May 16, 2006 (initiated Feb 6, 2006) |
| Status | Terminated |
| Reason | 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 | 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 | 58 units |
| Distribution | The units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051523 | REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION Konica Minolta Medical & Graphic, Inc., Jul 20, 2005 |