Recall Z-1391-05 ยท LMA Digitizer, Image, Radiological
Konica Medical Imaging, Inc.
Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.
| Date | Aug 13, 2005 (initiated Mar 30, 2005) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | The firm contacted all customers of the problem on 4/7/2005. |
| Quantity | 60 |
| Distribution | These units have been distributed to hospitals and clinics nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.