Class 3 Device Recall Regius

• Date Initiated by Firm: March 30, 2005
• Date Posted: August 13, 2005
• Recall Status: Terminated on August 31, 2005
• Recall Number: Z-1391-05
• Recall Event ID: 32068
• Product Classification: Digitizer, Image, Radiological - Product Code LMA
• Product: Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.
• Code Information: All serial numbers.
• FEI Number: 2241281
• Recalling Firm/ Manufacturer: Konica Medical Imaging, Inc.; 411 Newark Pompton Tpke; Wayne NJ 07470-6657
• For Additional Information Contact: Cliff Hults; 973-934-1034 Ext. 1362
• Manufacturer Reason for Recall: One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.
• FDA Determined Cause: Other
• Action: The firm contacted all customers of the problem on 4/7/2005.
• Quantity in Commerce: 60
• Distribution: These units have been distributed to hospitals and clinics nationwide.
• 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.