Primus

• • Terminated Z-1680-2020 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-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-1402-2018 FDA Class II ·initiated 14 Feb 2018
  • Terminated Z-1397-2018 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-1489-2017 FDA Class II ·initiated 14 Feb 2017

  Software update

• • Terminated Z-1215-2017 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-1432-2017 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.

• • Terminated Z-2877-2016 FDA Class II ·initiated 26 Jul 2016

  Software patch installation to address several safety issues.

• • 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-0980-2015 FDA Class II ·initiated 2 Dec 2014

  Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose must be considered in the overall dose calculation, or an overdose and serious injury may occur.

• • Terminated Z-2095-2013 FDA Class II ·initiated 18 Jul 2013

  Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, the screws holding the side rails in position on the tabletop might break off.

• • 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-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-0782-2012 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.

• • 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-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-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-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.

• 4 recalls, same reason

  • Terminated Z-2640-2011 FDA Unclassified (pre-2012) ·initiated 4 Nov 2010
  • Terminated Z-2643-2011 FDA Unclassified (pre-2012) ·initiated 4 Nov 2010
  • Terminated Z-2644-2011 FDA Unclassified (pre-2012) ·initiated 4 Nov 2010
  • Terminated Z-2641-2011 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-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.

• 3 recalls, same reason

  • Terminated Z-1396-2008 FDA Unclassified (pre-2012) ·initiated 11 Jan 2008
  • Terminated Z-1398-2008 FDA Unclassified (pre-2012) ·initiated 11 Jan 2008
  • Terminated Z-1397-2008 FDA Unclassified (pre-2012) ·initiated 11 Jan 2008

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

• • Terminated Z-1759-2008 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.

• 2 recalls, same reason

  • Terminated Z-0686-2008 FDA Unclassified (pre-2012) ·initiated 7 Aug 2007
  • Terminated Z-0687-2008 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-0850-2008 FDA Unclassified (pre-2012) ·initiated 27 Jul 2007

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

• • Terminated Z-0380-2008 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007

  Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.

• 4 recalls, same reason

  • Terminated Z-0166-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0167-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0169-2008 FDA Unclassified (pre-2012) ·initiated 22 Mar 2007
  • Terminated Z-0168-2008 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."

• • Terminated Z-0355-06 FDA Unclassified (pre-2012) ·initiated 8 Jan 2003

  Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas.

• 9 recalls, same reason

  • Terminated Z-1044-2013 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-1036-2013 FDA Class II ·initiated 5 Mar 13
  • Terminated Z-1040-2013 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-1042-2013 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 May 2015 Recall initiated FDA recalls Z-0168-2016
2. 5 Aug 2015 Recall initiated FDA recalls Z-2812-2015
3. 26 Jul 2016 Recall initiated FDA recalls Z-2877-2016
4. 25 Jan 2017 Recall initiated FDA recalls Z-1215-2017
5. 25 Jan 2017 Recall initiated FDA recalls Z-1432-2017
6. 14 Feb 2017 Recall initiated FDA recalls Z-1489-2017
7. 14 Feb 2018 Recall initiated FDA recalls Z-1402-2018
8. 14 Feb 2018 Recall initiated FDA recalls Z-1397-2018
9. 20 Mar 2019 Recall initiated FDA recalls Z-1204-2019
10. 18 Feb 2020 Recall initiated FDA recalls Z-1680-2020

41 earlier events are in the sections above.

510(k) Number

K993425 ↗

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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