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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 Recall
Siemens Axiom Sensis XP
see related information
Date Posted May 10, 2012
Recall Status1 Terminated on January 24, 2014
Recall Number Z-1506-2012
Recall Event ID 61517
Premarket Notification
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, Pennsylvania 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.
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 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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