Z-1564-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- March 25, 2016
- Termination Date
- May 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 kits
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution to OH, TX. FL, CA and GA.
Code Information
Lot number 20151117