Modification to: Revolution Xr/D Digital Radiographic Imaging System with Image Pasting and Autopositioning

• 2 recalls, same reason

  • Terminated Z-0585-2012 FDA Unclassified (pre-2012) ·initiated 22 Nov 2011
  • Terminated Z-0584-2012 FDA Unclassified (pre-2012) ·initiated 22 Nov 2011

  GE Healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the Definium 8000 and Discovery XR650 image pasting systems that may impact patient and user safety. The patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. Thi

510(k) Number

K050704 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Generator, High Volt, X-Ray, Diag. MPX80

  Class I

  FDA 510(k) K802548 Active Cleared 2 Dec 1980

• Senograph Ds, Senograph Essenstial

  Class II

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• Senographe Ds, Senographe Essential

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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

• Series 620 Rectal Probe Cover

  Class II

  FDA 510(k) K864222 Active Cleared 4 Mar 1987

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