Z-1481-06

Regius Model 370 Digital Radiography Konica Minolta

Name: Z-1481-06 Regius Model 370 Digital Radiography Konica Minolta
Creator: Konica Minolta Medical Imaging USA, Inc.
Published: 2006-07-14
License: https://open.fda.gov/license/

Konica Minolta, Inc. / initiated 2006-07-14 / Terminated

FDA source

Konica Minolta Medical Imaging USA, Inc. began a recall of Regius Model 370 Digital Radiography Konica Minolta on 2006-07-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1481-06
Status: Terminated
Initiated: 2006-07-14
Posted: 2006-08-31
Terminated: 2006-09-05
Recalling firm: Konica Minolta, Inc.
Product: Regius Model 370 Digital Radiography Konica Minolta
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
FDA 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 in commerce: 1 in US
Distribution: Texas
Product codes and lots: Serial # 0729-0005

Product code MQB

K051418Class IIDirect Digitizer Regius Model 370Konica Minolta Medical & Graphic, Inc. / cleared 2005-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)