FDA-Device2015-03-04Class II
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Iba Dosimetry Gmbh
Hazard
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.
Sold states
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.
Affected count
124 units
Manufactured in
Bahnhofstr. 5, N/A, Schwarzenbruck, N/A, Germany
Products
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1212-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief