Varian C-Series Clinacs Clinac 600C, 2100C, 2500C

• • 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) K904364

  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-1003-2011 FDA Unclassified (pre-2012) ·initiated 19 Apr 2010

  The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.

• • Terminated Z-1729-2009 FDA Unclassified (pre-2012) ·initiated 29 May 2009

  Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly.

• • Terminated Z-0117-2009 FDA Unclassified (pre-2012) ·initiated 11 Aug 2008

  During couch movement, a patient's fingers may get pinched at certain points which could result in broken, disengaged or pinched fingers.

• • 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.

• • Terminated Z-0777-05 FDA Unclassified (pre-2012) ·initiated 4 Feb 2005

  Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.

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

510(k) Number

K904364 ↗

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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