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Devices
Device Recall Magellan Robotic System
Model / Serial
All serial numbers.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
Product Description
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Manufacturer
Hansen Medical Inc
1 Event
Recall of Device Recall Magellan Robotic System
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Manufacturer
Hansen Medical Inc
Manufacturer Address
Hansen Medical Inc, 800 E Middlefield Rd, Mountain View CA 94043-4030
Manufacturer Parent Company (2017)
Auris Health, Inc.
Source
USFDA
Language
English
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