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Recall Observatory FDA recall evidence

Device product

Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.

Z-1449-2015

March 18, 2015

Class II

Product summary

Firm
Hansen Medical Inc
Event
Event 70847
Status
Terminated
Classification
Class II
Quantity
19 total installed systems
Official record key
device-enforcement:Z-1449-2015

Official wording

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.

Code information: All serial numbers.

Distribution pattern: Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.