Z-1449-2015 Class II Terminated
FDA device recall Z-1449-2015 was initiated by Hansen Medical Inc on March 18, 2015 and is designated Class II. Reason for recall: 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. … The recall status is terminated (terminated September 23, 2015). Affected quantity: 19 total installed systems.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2015
- Initiation Date
- March 18, 2015
- Termination Date
- September 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 total installed systems
Product Description
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
Code Information
All serial numbers.