Mevatron, M 2 Class

• 2 recalls, same reason

  • Terminated Z-1679-2020 FDA Class II ·initiated 18 Feb 2020
  • Terminated Z-1678-2020 FDA Class II ·initiated 18 Feb 2020

  Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

• • Terminated Z-1436-2017 FDA Class II ·initiated 25 Jan 2017

  Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.

• 18 recalls, same reason

  • Terminated Z-0790-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0794-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0797-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0792-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0781-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0788-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0793-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0798-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0795-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0787-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0786-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0780-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0785-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0789-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0791-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0783-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0784-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011
  • Terminated Z-0796-2012 FDA Unclassified (pre-2012) ·initiated 1 Dec 2011

  Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.

• 2 recalls, same reason

  • Terminated Z-1402-2008 FDA Unclassified (pre-2012) ·initiated 11 Jan 2008
  • Terminated Z-1401-2008 FDA Unclassified (pre-2012) ·initiated 11 Jan 2008

  Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.

• 5 recalls, same reason

  • Terminated Z-0679-2008 FDA Unclassified (pre-2012) ·initiated 7 Aug 2007
  • Terminated Z-0682-2008 FDA Unclassified (pre-2012) ·initiated 7 Aug 2007
  • Terminated Z-0684-2008 FDA Unclassified (pre-2012) ·initiated 7 Aug 2007
  • Terminated Z-0678-2008 FDA Unclassified (pre-2012) ·initiated 7 Aug 2007
  • Terminated Z-0683-2008 FDA Unclassified (pre-2012) ·initiated 7 Aug 2007

  Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

• • Terminated Z-0852-2008 FDA Unclassified (pre-2012) ·initiated 27 Jul 2007

  Door Hinge failures; loose or falling off (Stationary Structure Doors)

• 9 recalls, same reason

  • Terminated Z-0156-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0157-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0159-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0158-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0163-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0160-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0155-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0162-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0161-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007

  Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

510(k) Number

K882729 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Z Xt Radiation Therapy Treatment Table

  Class II

  FDA 510(k) K910971 Active Cleared 3 May 1991

• Sonoline Cf

  Class II

  FDA 510(k) K875272 Active Cleared 18 Feb 1988

• Mevatron 74X Medical Linear Accelerator

  Class II

  FDA 510(k) K791967 Active Cleared 16 Nov 1979

• Mevatron Kd-2

  Class II

  FDA 510(k) K862339 Active Cleared 29 Oct 1986

• Mevatron 67

  Class II

  FDA 510(k) K790688 Active Cleared 23 Apr 1979

• Mevatron 60

  Class II

  FDA 510(k) K790388 Active Cleared 26 Mar 1979

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