Recall Z-1449-2015 ยท DXX System, Catheter Control, Steerable
Hansen Medical Inc
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
| Date | Apr 15, 2015 (initiated Mar 18, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 19 total installed systems |
| Distribution | Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom. |
| FDA record | Open on fda.gov |