Dolphin E3062020

• FDA 510(k) K072374 decided 7 Dec 2007 Active
• FDA GUDID UDI-DI EIBAE30620200 listed 9 Sep 2016 Listed

• • Terminated Z-1212-2015 FDA Class II ·initiated 2 Feb 2015

  Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.

• • Terminated Z-0168-2015 FDA Class II ·initiated 25 Sep 2014

  Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.

• • Terminated Z-0456-2014 FDA Class II ·initiated 20 Aug 2013

  The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.

1. 7 Dec 2007 Cleared FDA 510(k) K072374
2. 20 Aug 2013 Recall initiated FDA recalls Z-0456-2014
3. 25 Sep 2014 Recall initiated FDA recalls Z-0168-2015
4. 2 Feb 2015 Recall initiated FDA recalls Z-1212-2015
5. 9 Sep 2016 Listed FDA GUDID EIBAE30620200

Trade name

Dolphin

Generic name

Radiation electrometer

Model / reference

E3062020

Primary DI / UDI-DI

EIBAE30620200

510(k) Number

K072374 ↗

FDA product code

IYE

GMDN term

Radiation electrometer

Device class

Class II

Regulation number

892.5050

GUDID distribution status

In Commercial Distribution

Category: Radiation electrometer

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