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U.S. Department of Health and Human Services

Class 2 Device Recall Magellan Robotic System

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  Class 2 Device Recall Magellan Robotic System see related information
Date Initiated by Firm March 18, 2015
Date Posted April 15, 2015
Recall Status1 Terminated 3 on September 23, 2015
Recall Number Z-1449-2015
Recall Event ID 70847
510(K)Number K111004  K132369  K141614  
Product Classification System, catheter control, steerable - Product Code DXX
Product Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Hansen Medical Inc
800 E Middlefield Rd
Mountain View CA 94043-4030
For Additional Information Contact Elisa Aldridge
650-404-2784
Manufacturer Reason
for Recall		 Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop when equipment button is released.
FDA Determined
Cause 2		 Software design
Action Hansen Medical sent an Urgent Notice - Field Safety Notice dated March 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. We request that you review the information in pages 1 and 2 with Hansen Medical personnel and acknowledge your understanding by signing the Field Safety Notice Training Form on page 3. If you need any further information regarding this issue, please do not hesitate to contact me via telephone at 650-404-2784.
Quantity in Commerce 19 total installed systems
Distribution Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
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 = DXX and Original Applicant = Hansen Medical
510(K)s with Product Code = DXX and Original Applicant = HANSEN MEDICAL, INC.
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