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Terminated

Regius Model 370 Digital Radiography Konica Minolta

FDA Recall Z-1481-06 · Posted 2006-08-31

Recalling FirmKonica Minolta Medical Imaging USA, Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2006-07-14
Date Terminated2006-09-05
Product Quantity1 in US

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Texas

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051418DIRECT DIGITIZER REGIUS MODEL 370Konica Minolta Medical & Graphic, Inc. · 2005-07-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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