Forte Gamma Camera System

• 3 recalls, same reason

  • Terminated Z-0215-2020 FDA Class I ·initiated 19 Sep 2019
  • Terminated Z-0214-2020 FDA Class I ·initiated 19 Sep 2019
  • Terminated Z-0217-2020 FDA Class I ·initiated 19 Sep 2019

  An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.

• • Terminated Z-1777-2015 FDA Class II ·initiated 6 Mar 2015

  The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

510(k) Number

K033254 ↗

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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  Class II

  FDA 510(k) K844784 Active Cleared 1 Feb 1985

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• Skylight Imaging System

  Class II

  FDA 510(k) K000908 Active Cleared 5 Apr 2000

• Adac Viewpoint (Additional Software)

  Class II

  FDA 510(k) K884349 Active Cleared 22 Dec 1988

See all devices from Adac Laboratories →