160MLC Option

• • Terminated Z-1493-2012 FDA Not yet classified ·initiated 3 Apr 2012

  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-2404-2011 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011

  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.

• 9 recalls, same reason

  • Terminated Z-1039-2013 FDA Class II ·initiated 5 Mar 13
  • Terminated Z-1037-2013 FDA Class II ·initiated 5 Mar 13
  • Terminated Z-1036-2013 FDA Class II ·initiated 5 Mar 13
  • Terminated Z-1040-2013 FDA Class II ·initiated 5 Mar 13
  • Terminated Z-1043-2013 FDA Class II ·initiated 5 Mar 13
  • Terminated Z-1042-2013 FDA Class II ·initiated 5 Mar 13
  • Terminated Z-1044-2013 FDA Class II ·initiated 5 Mar 13
  • Terminated Z-1041-2013 FDA Class II ·initiated 5 Mar 13
  • Terminated Z-1038-2013 FDA Class II ·initiated 5 Mar 13

  Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.

1. 5 Mar 13 Recall initiated FDA recalls Z-1036-2013
2. 5 Mar 13 Recall initiated FDA recalls Z-1040-2013
3. 5 Mar 13 Recall initiated FDA recalls Z-1043-2013
4. 5 Mar 13 Recall initiated FDA recalls Z-1042-2013
5. 5 Mar 13 Recall initiated FDA recalls Z-1044-2013
6. 5 Mar 13 Recall initiated FDA recalls Z-1041-2013
7. 5 Mar 13 Recall initiated FDA recalls Z-1038-2013
8. 18 Sep 2009 Cleared FDA 510(k) K092145
9. 15 Apr 2011 Recall initiated FDA recalls Z-2404-2011
10. 3 Apr 2012 Recall initiated FDA recalls Z-1493-2012

2 earlier events are in the sections above.

510(k) Number

K092145 ↗

FDA product code

IYE

Device class

Class II

Regulation

21 CFR Part 892.5050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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