Regius Model 370 Digital Radiography Konica Minolta
FDA device recall Z-1481-06 · posted 2006-08-31 · Terminated
Recall details
- Recalling firm
- Konica Minolta Medical Imaging USA, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 1 in US
- Distribution
- Texas
- Date initiated
- 2006-07-14
- Date posted
- 2006-08-31
- Date terminated
- 2006-09-05
- 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 |
|---|---|---|
| DIRECT DIGITIZER REGIUS MODEL 370 (K051418) | Konica Minolta Medical & Graphic, Inc. | 2005-07-01 |