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Recall Observatory FDA recall evidence

Device product

COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

Z-0168-2015

September 25, 2014

Class II

Product summary

Firm
Iba Dosimetry Gmbh
Event
Event 69583
Status
Terminated
Classification
Class II
Quantity
124 units
Official record key
device-enforcement:Z-0168-2015

Official wording

Reason: 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.

Code information: N/A

Distribution pattern: Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Error in the software