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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