FDAFDA · Food and drugs·Recall number Z-1449-2015
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Published April 22, 2015 · Recall initiated: March 18, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Hansen Medical Inc
- Distributor
- Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
- Lot
- All serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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