Z-1506-2012

Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer

Name: Z-1506-2012 Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-02-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-02-22 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer on 2012-02-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1506-2012
Status: Terminated
Initiated: 2012-02-22
Posted: 2012-05-10
Terminated: 2014-01-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 3
Distribution: Nationwide Distribution including FL, NC, and SC.
Product codes and lots: Model number 10608285 - serial numbers 41021, 10006, and 6045.

Product code DQK

K020440Class IINewcorSiemens Medical Systems, Inc. / cleared 2002-12-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)