FDA Medical Device Recalls (openFDA)
Konica Minolta Medical Imaging USA, Inc.: Regius Model 370 Digital Radiography Konica Minolta
- Recall number
- Z-1481-06
- Recalling firm
- Konica Minolta Medical Imaging USA, Inc.
- Product
- Regius Model 370 Digital Radiography Konica Minolta
- Status
- Terminated
- Initiated
- 2006-07-14
- Posted
- 2006-08-31
- Terminated
- 2006-09-05
- 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
- Lot, serial or model codes
- Serial # 0729-0005
- 510(k) numbers
- ["K051418"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2241281
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28