1525717

• FDA 510(k) K051932 decided 12 Aug 2005 Active
• FDA GUDID UDI-DI 05060191071017 listed 24 Sep 2016 Listed

• • Terminated Z-2840-2018 FDA Class II ·initiated 1 Dec 2017

  There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.

• • Terminated Z-2721-2016 FDA Class II ·initiated 8 Jul 2016

  There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

• • Terminated Z-1088-2015 FDA Class II ·initiated 7 Jan 2015

  Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.

• • Terminated Z-1061-2014 FDA Class II ·initiated 25 Nov 2013

  Potential collision risk when using XVI and external beam shaping devices.

• • Terminated Z-1065-2014 FDA Class II ·initiated 28 May 2013

  Customers are resetting the default values outside recommended factory settings.

• • Terminated Z-0931-2013 FDA Class II ·initiated 19 Dec 2012

  The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.

• • Terminated Z-2405-2012 FDA Class II ·initiated 6 Aug 2012

  There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

• • Terminated Z-3079-2011 FDA Unclassified (pre-2012) ·initiated 6 May 2011 ·on shared 510(k) K051932

  A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.

• • Terminated Z-0305-2012 FDA Unclassified (pre-2012) ·initiated 9 Mar 2011

  If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a a zero value.

• • Terminated Z-1252-2011 FDA Unclassified (pre-2012) ·initiated 5 Jan 2011

  Flexmap calibration did not cover the full 360 degrees of gantry rotation (0 to 355 degrees) and that this caused an isocenter displacement with 2D PlanarView images required at 180 to -180.

• • Terminated Z-1723-2011 FDA Unclassified (pre-2012) ·initiated 25 Oct 2010

  If another patient is selected on the imaging system (XVI) release 4.5) during the transmission of end of treatment data from Desktop Pro R7.01 to R&V system, the XVI information is prioritized and the end of treatment data is never received by the R&V system.

• • Terminated Z-0350-2011 FDA Unclassified (pre-2012) ·initiated 1 Sep 2010

  It is possible to do couch corrections twice if both Couch Move Assistant in MOSAIQ and Remote Automatic Table in XVI are configured when in SYNERGISTIQ mode.

• • Terminated Z-1405-2010 FDA Unclassified (pre-2012) ·initiated 12 Dec 2008

  It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing.

• • Terminated Z-1411-2010 FDA Unclassified (pre-2012) ·initiated 19 Sep 2007

  Firm became aware of a failure in the position detection system which could result in incorrect positioning of the detector in the longitudinal or lateral direction.

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

1. 9 Mar 2011 Recall initiated FDA recalls Z-0305-2012
2. 6 May 2011 Recall initiated FDA recalls Z-3079-2011
3. 6 Aug 2012 Recall initiated FDA recalls Z-2405-2012
4. 19 Dec 2012 Recall initiated FDA recalls Z-0931-2013
5. 28 May 2013 Recall initiated FDA recalls Z-1065-2014
6. 25 Nov 2013 Recall initiated FDA recalls Z-1061-2014
7. 7 Jan 2015 Recall initiated FDA recalls Z-1088-2015
8. 8 Jul 2016 Recall initiated FDA recalls Z-2721-2016
9. 24 Sep 2016 Listed FDA GUDID 05060191071017
10. 1 Dec 2017 Recall initiated FDA recalls Z-2840-2018

6 earlier events are in the sections above.

Generic name

Linear accelerator system

Model / reference

1525717

Primary DI / UDI-DI

05060191071017

510(k) Number

K051932 ↗

FDA product code

IYE

GMDN term

Linear accelerator system

Device class

Class II

Regulation number

892.5050

GUDID distribution status

In Commercial Distribution

Category: Linear accelerator system

• XVI 1526927

  Class II

  FDA 510(k) K131965 Active Cleared 25 Sep 2013 GUDID on market

• Elekta Unity 1536549

  Class II

  FDA 510(k) K182076 Active Cleared 4 Dec 2018 GUDID on market

• 1525333

  Class II

  FDA 510(k) K051932 Active Cleared 12 Aug 2005 GUDID on market

• 1525332

  Class II

  FDA 510(k) K051932 Active Cleared 12 Aug 2005 GUDID on market

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