Class 2 Device Recall

• Date Initiated by Firm: March 11, 2003
• Date Posted: June 05, 2003
• Recall Status: Terminated on May 12, 2004
• Recall Number: Z-0905-03
• Recall Event ID: 26260
• Product Classification: Device, Digital Image Storage, Radiological - Product Code LMB
• Product: Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx
• Code Information: RIUpdate 7.1.0K
• FEI Number: 3017088497
• Recalling Firm/ Manufacturer: Canon USA Inc; 15955 Alton Parkway; Irvine CA 92618
• For Additional Information Contact: Brian j. Donato; 949-553-7400
• Manufacturer Reason for Recall: Imaging archive system software mismatches images and patient names.
• FDA Determined Cause: Other
• Action: Recall letters were sent March 11, 2003. Another mailing was sent March 26, 2003 with stickers and preventative practice suggestions. A software fix will be available to customers in the near future.
• Quantity in Commerce: 34
• Distribution: States of IA, CA , AR, WA, OR
• 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.