Dec

2013

Cl II iba COMPASS SW Version 3.0

Company: Iba Dosimetry Gmbh
Date of Enforcement Report:12/18/2013
Class lI:

PRODUCT

iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological Recall Number Z-0456-2014

REASON
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.

RECALLING FIRM/MANUFACTURER
Iba Dosimetry Gmbh, Schwarzenbruck, DE on 8/20//2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
33 Units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II iba COMPASS SW Version 3.0

Amy Sellers

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