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Terminated

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

FDA Recall Z-0905-03 · Posted 2003-06-05

Recalling FirmCanon USA Inc
Recall StatusTerminated
Product CodeLMB
Date Initiated2003-03-11
Date Terminated2004-05-12
Product Quantity34

Reason for Recall

Imaging archive system software mismatches images and patient names.

Firm 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.

Root Cause

Other

Distribution Pattern

States of IA, CA , AR, WA, OR

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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