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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/
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 2		 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.
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