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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DXX 510(K)s with Product Code = DXX
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