REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throu
FDA device recall Z-0862-06 · posted 2006-05-16 · Terminated
Recall details
- Recalling firm
- Konica Minolta Medical Imaging USA, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 58 units
- Distribution
- The units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts.
- Date initiated
- 2006-02-06
- Date posted
- 2006-05-16
- Date terminated
- 2008-08-22
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION (K051523) | Konica Minolta Medical & Graphic, Inc. | 2005-07-20 |