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U.S. Department of Health and Human Services

Class 2 Device Recall REGIUS IM, RIM

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 Class 2 Device Recall REGIUS IM, RIMsee related information
Date Initiated by FirmFebruary 06, 2006
Date PostedMay 16, 2006
Recall Status1 Terminated 3 on August 22, 2008
Recall NumberZ-0862-06
Recall Event ID 34785
510(K)NumberK051523 
Product Classification System, Image Processing, Radiological - Product Code LLZ
ProductREGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction.
Code Information 58 units distributed between June 2003 and January 2006. Software version prior to January 31, 2006.
Recalling Firm/
Manufacturer		 Konica Minolta Medical Imaging USA, Inc.
411 Newark Pompton Tpke
Wayne NJ 07470-6657
For Additional Information ContactClifford Hults
800-934-1034 Ext. 1362
Manufacturer Reason
for Recall		If the patient demographic data is entered into the CS-1 manually, and the user fails to enter any data in one of the demographic data fields labeled as Birthday, Sex, Name or Patient Comments, etc, the RIM will populate the fields where no data has been entered with data from the previous patient.
FDA Determined
Cause 2		Other
ActionThe firm phoned the customers on 2/6/2006 to inform them of the recall and the corrective action associated to the recall. This will be followed up with a fax, e-mail and letter. The final step will be visiting the location to install the correct software.
Quantity in Commerce58 units
DistributionThe units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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