Sequencer

• • Ongoing Z-0821-2019 FDA Class II ·initiated 13 Dec 2018

  There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.

• • Terminated Z-1270-2012 FDA Not yet classified ·initiated 14 Feb 2012

  Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, for RT Therapist version 2.1A

• • Terminated Z-0052-2012 FDA Unclassified (pre-2012) ·initiated 9 Sep 2011

  Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq.

• • Terminated Z-2662-2011 FDA Unclassified (pre-2012) ·initiated 10 Mar 2011

  There's a problem in the database conversion program that is used when upgrading from the Multi-ACCS to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.

• • Terminated Z-0076-2011 FDA Unclassified (pre-2012) ·initiated 2 Sep 2010

  Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient.

• • Terminated Z-1029-2011 FDA Unclassified (pre-2012) ·initiated 10 Mar 2010

  Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.

• • Terminated Z-0159-2011 FDA Unclassified (pre-2012) ·initiated 19 Feb 2010 ·on shared 510(k) K981313

  Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.

• • Terminated Z-1027-2011 FDA Unclassified (pre-2012) ·initiated 17 Jul 2009

  Potential for improper treatment. A software error may result in potential major underdosing to targeted areas from jaw blockage of the MLC aperture (jaw intrusion), and dosing to non-targeted areas from interstitial leaf leakage (jaw extrusion).

• • Terminated Z-1515-2008 FDA Unclassified (pre-2012) ·initiated 14 Feb 2008

  Software issue may result in change to intended treatment field, potentially resulting in mistreatment.

• • Terminated Z-1401-06 FDA Unclassified (pre-2012) ·initiated 7 Jul 2006

  Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.

• • Terminated Z-0364-06 FDA Unclassified (pre-2012) ·initiated 6 Jan 2005

  When using the Creatine Clearance dose calculations a software bug will allow the algorithm to assume a patients age to be in years when it is entered in months. This miscalculation may result in patients less than two years old to be seriously overdosed with radiation.

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

1. 7 Jul 2006 Recall initiated FDA recalls Z-1401-06
2. 14 Feb 2008 Recall initiated FDA recalls Z-1515-2008
3. 17 Jul 2009 Recall initiated FDA recalls Z-1027-2011
4. 19 Feb 2010 Recall initiated FDA recalls Z-0159-2011
5. 10 Mar 2010 Recall initiated FDA recalls Z-1029-2011
6. 2 Sep 2010 Recall initiated FDA recalls Z-0076-2011
7. 10 Mar 2011 Recall initiated FDA recalls Z-2662-2011
8. 9 Sep 2011 Recall initiated FDA recalls Z-0052-2012
9. 14 Feb 2012 Recall initiated FDA recalls Z-1270-2012
10. 13 Dec 2018 Recall initiated FDA recalls Z-0821-2019

2 earlier events are in the sections above.

510(k) Number

K981313 ↗

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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