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U.S. Department of Health and Human Services

Class 3 Device Recall Regius

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  Class 3 Device Recall Regius see related information
Date Initiated by Firm July 14, 2006
Date Posted August 31, 2006
Recall Status1 Terminated 3 on September 05, 2006
Recall Number Z-1481-06
Recall Event ID 36109
510(K)Number K051418  
Product Classification radiography machine - Product Code MQB
Product Regius Model 370 Digital Radiography
Konica Minolta
Code Information Serial # 0729-0005
Recalling Firm/
Manufacturer		 Konica Minolta Medical Imaging USA, Inc.
411 Newark Pompton Tpke
Wayne NJ 07470-6657
For Additional Information Contact Clifford Hults
800-934-1034 Ext. 1362
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = KONICA MINOLTA MEDICAL & GRAPHIC, INC.
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