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Hansen Medical Inc recalls Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan S
Recalled May 4, 2016 · FDA recall Z-1564-2016 · Hansen Medical
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. · FDA Class II
Units
8 kits
Sold at
Nationwide Distribution to OH, TX. FL, CA and GA.
Description
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.
Product
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.
Manufacturer(s)
Hansen Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →