FDA Medical Device Recalls (openFDA)
Canon USA Inc: Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx
- Recall number
- Z-0905-03
- Recalling firm
- Canon USA Inc
- Product
- Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx
- Status
- Terminated
- Initiated
- 2003-03-11
- Posted
- 2003-06-05
- Terminated
- 2004-05-12
- Reason
- Imaging archive system software mismatches images and patient names.
- 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
- 34
- Distribution
- States of IA, CA , AR, WA, OR
- Lot, serial or model codes
- RIUpdate 7.1.0K
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LMB
- Firm FEI
- 3017088497
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28