Device 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.
Z-1564-2016
Product summary
- Event
- Event 73677
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 kits
- Official record key
device-enforcement:Z-1564-2016
Official wording
Reason: 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.
Code information: Lot number 20151117
Distribution pattern: Nationwide Distribution to OH, TX. FL, CA and GA.
Derived failure modes
-
Unknown
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.