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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Axiom Sensis XP

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  Class 2 Device Recall Siemens Axiom Sensis XP see related information
Date Initiated by Firm February 22, 2012
Date Posted May 10, 2012
Recall Status1 Terminated 3 on January 24, 2014
Recall Number Z-1506-2012
Recall Event ID 61517
510(K)Number K020440  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Siemens Axiom Sensis XP diagnostic programmable computer

Diagnostic programmable computer
Code Information Model number 10608285 - serial numbers 41021, 10006, and 6045.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Anastasia Mason
610-219-6300
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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