Artiste Mv SA

• • Terminated Z-1677-2020 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.

• • Terminated Z-1488-2017 FDA Class II ·initiated 14 Feb 2017

  Software update

• • Terminated Z-1212-2017 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-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-2180-2014 FDA Class II ·initiated 17 Jun 2014

  Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data.

• • Terminated Z-2174-2014 FDA Class II ·initiated 28 May 2014

  A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.

• • Terminated Z-1645-2014 FDA Class II ·initiated 1 Apr 2014

  Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.

• • Terminated Z-1652-2014 FDA Class II ·initiated 1 Apr 2014

  Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models.

• • Terminated Z-0438-2014 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-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-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-1422-2011 FDA Unclassified (pre-2012) ·initiated 3 Dec 2010

  The firm become aware of a potential issue with ARTISTE system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient.

• • Terminated Z-1523-2011 FDA Unclassified (pre-2012) ·initiated 29 Jun 2010

  A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment.

• • Terminated Z-0449-2011 FDA Unclassified (pre-2012) ·initiated 22 Jan 2010

  The robotic lift armature shaft may break and allow the Flat Panel Positioner with the digital flat panel imager to fall into the Flat Panel cradle. If the positioner is over a patient, there is a potential for injury.

• • Terminated Z-0121-2010 FDA Unclassified (pre-2012) ·initiated 10 Sep 2009

  A failed data transfer is possible that may result in data not being recorded in the interfaced system. Siemens Medical Solutions, Inc. USA became aware of this potential issue with its ARTISTE Linear Accelerator's Syngo RT Therapist v4.1 Workspace (containing the Siemens brand of Verify and Record application called PRIMEVIEW) and the LANTIS Oncology Information System product.

• • 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-1064-2011 FDA Unclassified (pre-2012) ·initiated 30 Jul 2009

  Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.

• • Terminated Z-1888-2009 FDA Unclassified (pre-2012) ·initiated 9 Apr 2009

  Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment

• • Terminated Z-0949-2009 FDA Unclassified (pre-2012) ·initiated 20 Dec 2008

  The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly.

• • Terminated Z-0857-2009 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008

  Under certain conditions, the flat panel may move unexpectedly and collide with the patient.

• • Terminated Z-0927-2009 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008

  If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstanc

• • Terminated Z-0116-2009 FDA Unclassified (pre-2012) ·initiated 4 Jul 2008

  Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images.

1. 1 Apr 2014 Recall initiated FDA recalls Z-1645-2014
2. 1 Apr 2014 Recall initiated FDA recalls Z-1652-2014
3. 28 May 2014 Recall initiated FDA recalls Z-2174-2014
4. 17 Jun 2014 Recall initiated FDA recalls Z-2180-2014
5. 2 Dec 2014 Recall initiated FDA recalls Z-0980-2015
6. 19 Dec 2014 Recall initiated FDA recalls Z-1059-2015
7. 25 Jan 2017 Recall initiated FDA recalls Z-1212-2017
8. 14 Feb 2017 Recall initiated FDA recalls Z-1488-2017
9. 20 Mar 2019 Recall initiated FDA recalls Z-1204-2019
10. 18 Feb 2020 Recall initiated FDA recalls Z-1677-2020

15 earlier events are in the sections above.

510(k) Number

K072485 ↗

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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