Prestige Remote R & F System Models H, Vh & Vhd

• • Terminated Z-1751-2019 FDA Class II ·initiated 29 Mar 2019

  There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

• 3 recalls, same reason

  • Terminated Z-0912-2017 FDA Class II ·initiated 21 Nov 2016
  • Terminated Z-0911-2017 FDA Class II ·initiated 21 Nov 2016
  • Terminated Z-0913-2017 FDA Class II ·initiated 21 Nov 2016

  GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.

• • Terminated Z-0804-2014 FDA Class II ·initiated 8 Nov 2013

  Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of the overhead monitor suspension.

510(k) Number

K943805 ↗

FDA Product Code

JAA

Models / Variants

H

Vh

Vhd

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K802548 Active Cleared 2 Dec 1980

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  Class II

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• GE CT/T 8800 System

  Class II

  FDA 510(k) K780326 Active Cleared 14 Mar 1978

• CT Pace Catalog Number B7950A

  Class II

  FDA 510(k) K872526 Active Cleared 23 Sep 1987

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  Class II

  FDA 510(k) K864222 Active Cleared 4 Mar 1987

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