Vertex Epic Mcd

• • Terminated Z-1598-2015 FDA Class II ·initiated 13 Mar 2015

  During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.

• • Terminated Z-1510-2014 FDA Class II ·initiated 10 Mar 2014

  Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.

510(k) Number

K952684 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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