Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer

FDA Recall Z-1506-2012 · Posted 2012-05-10

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeDQK
Date Initiated2012-02-22
Date Terminated2014-01-24
Product Quantity3

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution including FL, NC, and SC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020440NEWCORSiemens Medical Systems, Inc. · 2002-12-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑