8600 Vital Signs Monitor

• • Terminated Z-0810-2014 FDA Class II ·initiated 21 Nov 2013

  The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor.

• • Terminated Z-1586-2013 FDA Class II ·initiated 15 Apr 2013

  The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.

• • Terminated Z-0259-2007 FDA Unclassified (pre-2012) ·initiated 29 Sep 2006

  Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.

510(k) Number

K042569 ↗

FDA Product Code

MWI

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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