COMPASS SW Version 3.1 recall: Software Issue
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Why was COMPASS SW Version 3.1 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model : SW Version 3.1 Lot or Serial Number : n.a
- Product
- COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
- Recalling firm
- Iba Dosimetry Gmbh
- Quantity
- 124 units
- Distribution
- 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.
- Recall date
- March 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)