Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer
FDA device recall Z-1506-2012 · posted 2012-05-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 3
- Distribution
- Nationwide Distribution including FL, NC, and SC.
- Date initiated
- 2012-02-22
- Date posted
- 2012-05-10
- Date terminated
- 2014-01-24
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWCOR (K020440) | Siemens Medical Systems, Inc. | 2002-12-03 |