RecallDepth

Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx

This recall has been terminated (originally issued June 5, 2003).

Company
Canon Usa Inc
Recall Initiated
March 11, 2003
Posted
June 5, 2003
Terminated
May 12, 2004
Recall Number
Z-0905-03
Quantity
34
Firm Location
Irvine, CA
Official Source
View on FDA website ↗

Reason for Recall

Imaging archive system software mismatches images and patient names.

Distribution

States of IA, CA , AR, WA, OR

Lot / Code Info

RIUpdate 7.1.0K

Root Cause

Other

Action Taken

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.