Recall record at a glance
| Official record | Z-1212-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Iba Dosimetry Gmbh |
| Report date | Mar 4, 2015 |
| Recall initiation date | Feb 2, 2015 |
| Quantity | 124 units |
| Location | Schwarzenbruck, N/A, Germany |
Official product description
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Why the product was 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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