Recall Z-0905-03 ยท LMB Device, Digital Image Storage, Radiological
Canon USA Inc
Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx
| Date | Jun 5, 2003 (initiated Mar 11, 2003) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.