FDAFDA · Food and drugs·Recall number Z-1564-2016
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
Published May 4, 2016 · Recall initiated: March 25, 2016
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
Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hansen Medical Inc
- Distributor
- Nationwide Distribution to OH, TX. FL, CA and GA.
- Lot
- Lot number 20151117
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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