Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Reported: November 20, 2013 Initiated: October 23, 2013 #Z-0281-2014
Product Description
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Reason for Recall
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
Details
- Recalling Firm
- RAYSEARCH LABORATORIES AB
- Units Affected
- 195 units domestically
- Distribution
- US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
- Location
- Stockholm
Frequently Asked Questions
What product was recalled? ▼
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 195 units domestically.
Why was this product recalled? ▼
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2013. Severity: Moderate. Recall number: Z-0281-2014.
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