Recall Z-1506-2012 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer
| Date | May 10, 2012 (initiated Feb 22, 2012) |
| Status | Terminated |
| Reason | There is a potential malfunction in the connection of a Sensis EP system with Carto(R) 3 dedicated cable set (part number 14411343) with the Carto 3 system from Bionsense Webster. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent a recall/correction letter dated February 22, 2012, via Update Instruction AX049/11/S of this product to all affected customers. The letter informed customers of the potential issues and provides additional information on the implemented resolution. An Update Instuction AX048/11/S will be available immediately. The update instruction provides a new version of the Carto 3 addendum to the Operator Manual and the exchange of the previous stim cables with the latest cable. For questions call 610-219-4834. |
| Quantity | 3 |
| Distribution | Nationwide Distribution including FL, NC, and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020440 | NEWCOR Siemens Medical Systems, Inc., Dec 3, 2002 |