Canon USA Inc Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx
Brand
Canon USA Inc
Lot Codes / Batch Numbers
RIUpdate 7.1.0K
Products Sold
RIUpdate 7.1.0K
Canon USA Inc is recalling Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx due to Imaging archive system software mismatches images and patient names.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Imaging archive system software mismatches images and patient names.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, IA, OR, WA
Page updated: Jan 10, 2026