Varian C-Series Clinacs (Clinac 2300C/D)

• • Terminated Z-1249-2011 FDA Unclassified (pre-2012) ·initiated 23 Jun 2010

  Position errors may result in misdelivery of radiation.

• • Terminated Z-0886-2011 FDA Unclassified (pre-2012) ·initiated 10 Jun 2010 ·on shared 510(k) K913119

  The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch.

• • Terminated Z-0910-2011 FDA Unclassified (pre-2012) ·initiated 8 Oct 2009

  Product may deliver radiation treatment to areas larger than intended,to healthy tissue.

• • Terminated Z-1074-2007 FDA Unclassified (pre-2012) ·initiated 2 May 2007

  The wedge tray may slip out of the Clinac interface mount during gantry rotation.

• • Terminated Z-0194-2007 FDA Unclassified (pre-2012) ·initiated 31 Aug 2006

  The chain holding the device gantry in position may break.

• • Terminated Z-1530-05 FDA Unclassified (pre-2012) ·initiated 30 Mar 2005

  Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K913119 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Bds-3 Beam Data Scanner

  Class I

  FDA 510(k) K844620 Active Cleared 1 Jul 1985

• Flouroscope, Mobile C-Arm Image Intens.

  Class II

  FDA 510(k) K760429 Active Cleared 23 Aug 1976

• Spectrophotometer Analysis Sys.

  Class I

  FDA 510(k) K771807 Active Cleared 28 Nov 1977

• Applicators for Varian Varisource Remote High Dose Rate Afterloader

  Class II

  FDA 510(k) K955844 Active Cleared 26 Jul 1996

• Spectrophotometer Analysis Sys., Aa-175

  Class I

  FDA 510(k) K770443 Active Cleared 8 Apr 1977

• Electron Beam Option for Clinac 15 Mev

  Class II

  FDA 510(k) K832502 Active Cleared 12 Sep 1983

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