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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 11, 2003
Date Posted June 05, 2003
Recall Status1 Terminated 3 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
Recalling Firm/
Canon USA Inc
15955 Alton Parkway
Irvine CA 92618
For Additional Information Contact Brian j. Donato
Manufacturer Reason
for Recall
Imaging archive system software mismatches images and patient names.
FDA Determined
Cause 2
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.