inforMED
MalfunctionMVJ

TMS

Received Jul 10, 2000 · Event occurred Jun 8, 2000

Report 8022247-2000-00005 · MDR key 285736

Device

Generic name

Radiation Treatment Planning System

Manufacturer

Helax Ab

Model number

TMS

Catalog number

HELAX-TMS VERSION 5.1

Lot number

*

Product problems

  • Application Program Problem: Dose Calculation Error

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

IT WAS REPORTED THAT AN INCORRECT DOSE IS CALCULATED WHEN USING COLLAPSED CONE FOR CERTAIN BEAM ANGLES.

Remedial action

  • Notification
  • Modification/Adjustment