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Hansen Medical Inc recalls Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Recalled April 22, 2015 · FDA recall Z-1449-2015 · Hansen Medical
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. · FDA Class II
Units
19 total installed systems
Sold at
Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
Description
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.
Product
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Manufacturer(s)
Hansen Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →