Z-0905-03

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

Name: Z-0905-03 Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx
Creator: Canon USA Inc
Published: 2003-03-11
License: https://open.fda.gov/license/

Canon Medical Components U.S.A., Inc. / initiated 2003-03-11 / Terminated / root cause: software

FDA source

Canon USA Inc began a recall of Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx on 2003-03-11. The reason FDA records is "Imaging archive system software mismatches images and patient names". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0905-03
Status: Terminated
Initiated: 2003-03-11
Posted: 2003-06-05
Terminated: 2004-05-12
Recalling firm: Canon Medical Components U.S.A., Inc.
Product: Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx
Product code: LMB Device, Digital Image Storage, Radiological
Reason for recall: Imaging archive system software mismatches images and patient names.
Root cause tag: software
FDA root cause: 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
Product codes and lots: RIUpdate 7.1.0K

Product code LMB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)