FDA-Device2015-04-22Class II
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Hansen Medical Inc
Hazard
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.
Sold states
Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
Affected count
19 total installed systems
Manufactured in
800 E Middlefield Rd, N/A, Mountain View, CA, United States
Products
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1449-2015Don't want to check this manually?
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