01
May
2024

FDA Recall: Software Error May Lead to Reported SSD to be Too High

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0

Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 5/1/2-24
Class II

PRODUCT

RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System

Recall Number:

Z-1742-2024

REASON:

Potential for reported SSD to be too high.

RECALLING FIRM/MANUFACTURER:

RAYSEARCH LABORATORIES AB

VOLUME OF PRODUCT IN COMMERCE:

9 units

DISTRIBUTION:

Worldwide distribution – US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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