COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Reported: November 12, 2014 Initiated: September 25, 2014 #Z-0168-2015
Product Description
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Reason for Recall
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.
Details
- Recalling Firm
- Iba Dosimetry Gmbh
- Units Affected
- 124 units
- Distribution
- 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.
- Location
- Schwarzenbruck, N/A
Frequently Asked Questions
What product was recalled? ▼
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological. Recalled by Iba Dosimetry Gmbh. Units affected: 124 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 12, 2014. Severity: Moderate. Recall number: Z-0168-2015.
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