Mevatron Kd-2

• • Terminated Z-1437-2017 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.

• 3 recalls, same reason

  • Terminated Z-2636-2011 FDA Unclassified (pre-2012) ·initiated 4 Nov 2010
  • Terminated Z-2638-2011 FDA Unclassified (pre-2012) ·initiated 4 Nov 2010
  • Terminated Z-2637-2011 FDA Unclassified (pre-2012) ·initiated 4 Nov 2010

  The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.

• • Terminated Z-1395-2008 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-1756-2008 FDA Unclassified (pre-2012) ·initiated 10 Dec 2007
  • Terminated Z-1753-2008 FDA Unclassified (pre-2012) ·initiated 10 Dec 2007
  • Terminated Z-1757-2008 FDA Unclassified (pre-2012) ·initiated 10 Dec 2007
  • Terminated Z-1755-2008 FDA Unclassified (pre-2012) ·initiated 10 Dec 2007
  • Terminated Z-1758-2008 FDA Unclassified (pre-2012) ·initiated 10 Dec 2007

  Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.

• • Terminated Z-1754-2008 FDA Unclassified (pre-2012) ·initiated 10 Dec 2007

  Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.

• 4 recalls, same reason

  • Terminated Z-0685-2008 FDA Unclassified (pre-2012) ·initiated 7 Aug 2007
  • Terminated Z-0680-2008 FDA Unclassified (pre-2012) ·initiated 7 Aug 2007
  • Terminated Z-0677-2008 FDA Unclassified (pre-2012) ·initiated 7 Aug 2007
  • Terminated Z-0681-2008 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-0851-2008 FDA Unclassified (pre-2012) ·initiated 27 Jul 2007

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

510(k) Number

K862339 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Mevatron, M 2 Class

  Class II

  FDA 510(k) K882729 Active Cleared 19 Sep 1988

• 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 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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