Recall Z-0034-05 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
| Date | Oct 22, 2004 (initiated Jul 9, 2004) |
| Status | Terminated |
| Reason | possible error calculating valve area with the AXIOM Sensis |
| Root cause | Other |
| Action | The recalling firm has issued a Customer Advisory to the affected customers per Update Instructions AX053/04/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence. |
| Quantity | 143 units |
| Distribution | The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020440 | NEWCOR Siemens Medical Systems, Inc., Dec 3, 2002 |