Oncor Expression

• • Terminated Z-2198-2019 FDA Class II ·initiated 10 Jul 2019

  Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability

• • Terminated Z-1204-2019 FDA Class II ·initiated 20 Mar 2019

  Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator.

• 2 recalls, same reason

  • Terminated Z-1399-2018 FDA Class II ·initiated 14 Feb 2018
  • Terminated Z-1400-2018 FDA Class II ·initiated 14 Feb 2018

  Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

• • Terminated Z-1491-2017 FDA Class II ·initiated 14 Feb 2017

  Software update

• • Terminated Z-1214-2017 FDA Class II ·initiated 25 Jan 2017

  Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.

• • Terminated Z-2812-2015 FDA Class II ·initiated 5 Aug 2015

  A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.

• • Terminated Z-0168-2016 FDA Class II ·initiated 5 May 2015

  potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option.

• • Terminated Z-1059-2015 FDA Class II ·initiated 19 Dec 2014

  A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke emission.

• • Terminated Z-0984-2015 FDA Class II ·initiated 19 Nov 2014

  There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.

• • Terminated Z-0437-2014 FDA Class II ·initiated 23 Oct 2013

  A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.

• • Terminated Z-1663-2013 FDA Class II ·initiated 29 May 2013

  The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may have resulted in mistreatment of patients.

• • Terminated Z-1182-2013 FDA Class II ·initiated 4 Apr 2013

  Software update to fix multiple safety related issues.

• • Terminated Z-1494-2012 FDA Not yet classified ·initiated 4 Apr 2012

  The firm became aware of a potential issue with Siemens-branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging panel if the panel does not retract before the gantry rotates; this may result in patient injury.

• • Terminated Z-1486-2012 FDA Not yet classified ·initiated 3 Apr 2012

  SIEMENS has received reports where a dropping down of the 550 TxT" Treatment Table was observed while the table was being moved downwards during operation by means of the hand control.

• • Terminated Z-1092-2012 FDA Not yet classified ·initiated 22 Jan 2012

  Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment.

• • Terminated Z-0459-2012 FDA Unclassified (pre-2012) ·initiated 9 Nov 2011

  Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.

• • Terminated Z-3003-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011

  A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image.

• • Terminated Z-2789-2011 FDA Unclassified (pre-2012) ·initiated 25 May 2011

  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-2216-2011 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011

  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-2243-2011 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011

  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-2190-2011 FDA Unclassified (pre-2012) ·initiated 24 Mar 2011

  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.

• • Terminated Z-1970-2011 FDA Unclassified (pre-2012) ·initiated 21 Aug 2009

  When editing the note type of a previously entered note, then reverting to the original type, data may be lost.

• • Terminated Z-2000-2011 FDA Unclassified (pre-2012) ·initiated 6 Mar 2009

  The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.

• 10 recalls, same reason

  • Terminated Z-2104-2008 FDA Unclassified (pre-2012) ·initiated 15 May 2008
  • Terminated Z-2100-2008 FDA Unclassified (pre-2012) ·initiated 15 May 2008
  • Terminated Z-2095-2008 FDA Unclassified (pre-2012) ·initiated 15 May 2008
  • Terminated Z-2097-2008 FDA Unclassified (pre-2012) ·initiated 15 May 2008
  • Terminated Z-2103-2008 FDA Unclassified (pre-2012) ·initiated 15 May 2008
  • Terminated Z-2098-2008 FDA Unclassified (pre-2012) ·initiated 15 May 2008
  • Terminated Z-2102-2008 FDA Unclassified (pre-2012) ·initiated 15 May 2008
  • Terminated Z-2101-2008 FDA Unclassified (pre-2012) ·initiated 15 May 2008
  • Terminated Z-2099-2008 FDA Unclassified (pre-2012) ·initiated 15 May 2008
  • Terminated Z-2096-2008 FDA Unclassified (pre-2012) ·initiated 15 May 2008

  Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.

• • Terminated Z-1400-2008 FDA Unclassified (pre-2012) ·initiated 11 Jan 2008

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

• 4 recalls, same reason

  • Terminated Z-1762-2008 FDA Unclassified (pre-2012) ·initiated 10 Dec 2007
  • Terminated Z-1760-2008 FDA Unclassified (pre-2012) ·initiated 10 Dec 2007
  • Terminated Z-1761-2008 FDA Unclassified (pre-2012) ·initiated 10 Dec 2007
  • Terminated Z-1763-2008 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.

• 11 recalls, same reason

  • Terminated Z-0095-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007
  • Terminated Z-0089-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007
  • Terminated Z-0092-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007
  • Terminated Z-0091-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007
  • Terminated Z-0099-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007
  • Terminated Z-0093-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007
  • Terminated Z-0098-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007
  • Terminated Z-0096-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007
  • Terminated Z-0094-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007
  • Terminated Z-0090-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007
  • Terminated Z-0097-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2007 ·on shared 510(k) K060226

  Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

• 11 recalls, same reason

  • Terminated Z-0972-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007
  • Terminated Z-0973-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007
  • Terminated Z-0976-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007
  • Terminated Z-0980-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007
  • Terminated Z-0974-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007
  • Terminated Z-0971-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007
  • Terminated Z-0975-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007
  • Terminated Z-0981-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007
  • Terminated Z-0977-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007
  • Terminated Z-0978-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007
  • Terminated Z-0979-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007

  Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference im

• • Terminated Z-1768-2008 FDA Unclassified (pre-2012) ·initiated 19 Sep 2007

  Images may potentially shift, causing an incorrect alignment of the patient, which may result in a dose to the wrong location. It was discovered through the complaint handling process that a potential image shift issue can occur after using the interactive shift tool and filtering tool due to incorrect consideration of the flat panel alignment.

• • Terminated Z-0165-2008 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."

• 9 recalls, same reason

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

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

510(k) Number

K060226 ↗

FDA product code

IYE

Device class

Class II

Regulation

21 CFR Part 892.5050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

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