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Recall Observatory FDA recall evidence

Device product

COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

Z-1212-2015

February 02, 2015

Class II

Product summary

Firm
Iba Dosimetry Gmbh
Event
Event 70545
Status
Terminated
Classification
Class II
Quantity
124 units
Official record key
device-enforcement:Z-1212-2015

Official wording

Reason: 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.

Code information: Model : SW Version 3.1 Lot or Serial Number : n.a

Distribution pattern: Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Error in the software