Recall Z-1481-06 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Konica Minolta Medical Imaging USA, Inc.
Regius Model 370 Digital Radiography Konica Minolta
| Date | Aug 31, 2006 (initiated Jul 14, 2006) |
| Status | Terminated |
| Reason | A hand grip column, even though locked in position, moved downward about 3 cm while a patient was holding the hand grip for lateral exposure. When the hand grip moved down, the patient who was holding it lost his or her balance and almost fell. This problem only occurred in Japan with one system. |
| Root cause | Other |
| Action | Konica Minolta USA contacted the site of the sole US user by phone on 7/14/06, followed by e-mail and certified mail/return receipt. |
| Quantity | 1 in US |
| Distribution | Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051418 | DIRECT DIGITIZER REGIUS MODEL 370 Konica Minolta Medical & Graphic, Inc., Jul 1, 2005 |