Modification to Hemcon Bandage and Hemcon Bandage Otc

• • Terminated Z-1493-2012 FDA Not yet classified ·initiated 3 Apr 2012 ·on shared 510(k) K072486

  Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment (issue 1). Additionally, there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2).

• • Terminated Z-2789-2011 FDA Unclassified (pre-2012) ·initiated 25 May 2011 ·on shared 510(k) K072486

  Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system

• • Terminated Z-2404-2011 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011 ·on shared 510(k) K072486

  Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment.

• • Terminated Z-2243-2011 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011 ·on shared 510(k) K072486

  Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location.

• • Terminated Z-2216-2011 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011 ·on shared 510(k) K072486

  Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and use the remote "Online 2D Image Review.

• • Terminated Z-2190-2011 FDA Unclassified (pre-2012) ·initiated 24 Mar 2011 ·on shared 510(k) K072486

  When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.

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

510(k) Number

K072486 ↗

FDA Product Code

QSY

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO

  Unclassified

  FDA 510(k) K150916 Active Cleared 10 Nov 2015

• Chitogauze, 2 in X 2 in, 8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY, Chitogauze, Packaging Strip, 1/2

  Unclassified

  FDA 510(k) K092357 Active Cleared 25 Aug 2009

• Chitogauze

  Unclassified

  FDA 510(k) K102546 Active Cleared 17 Nov 2010

• Chitogauze Fusion

  Unclassified

  FDA 510(k) K111163 Active Cleared 17 May 2011

• Prometheus ChitoGauze XR PRO

  Unclassified

  FDA 510(k) K153582 Active Cleared 25 May 2016

• Guardacare

  Unclassified

  FDA 510(k) K103641 Active Cleared 16 Jun 2011

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