Recall Z-1446-04 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
| Date | Sep 14, 2004 (initiated May 17, 2004) |
| Status | Terminated |
| Reason | Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab. |
| Root cause | Other |
| Action | The recalling firm issued a Customer Safety Advisory to their customers via certified mail on 5/17/04 to inform them of the problem. The advisory provides Update Instructions AX031/04/S to prevent this problem from occurring until the software upgrade is installed to correct the problem. |
| Quantity | 234 units |
| Distribution | The product was shipped to 43 medical facilities nationwide and one government account in KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020440 | NEWCOR Siemens Medical Systems, Inc., Dec 3, 2002 |