RegWardenFDA facility compliance records
Facility

IBA Dosimetry GmbH

6 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2015: 2 recalls; 2017: 1 recalls; 2025: 1 recalls1’131’142’15’161’17’18’19’20’21’22’23’241’25’26
  • Recalls (6)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2025-04-01
    Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
  • Class IITerminated2017-04-26
    When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDs at shallow depths and geometric shadowing of measured profiles may appear.
  • Class IITerminated2015-12-10
    When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.
  • Class IITerminated2015-02-02
    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.
  • Class IITerminated2014-09-25
    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.
  • Class IITerminated2013-08-20
    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 stat…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “IBA Dosimetry GmbH (FEI 3006653576) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006653576-iba-dosimetry-gmbh/

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