Bio-Console, Model 560

• • Terminated Z-1939-2010 FDA Unclassified (pre-2012) ·initiated 21 Apr 2010

  The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy being interrupted. This Field Notificatio

510(k) Number

K051303 ↗

FDA Product Code

DWA

Device Class

Class II

Regulation

21 CFR Part 870.4380

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Bio-Console 560

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