RayStation 13.0.0.1547 recall
RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Why was RayStation 13.0.0.1547 recalled?
Potential for reported SSD to be too high.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI: 0735000201054920220616, 0735000201067920221007 and 0735000201073020230913; GTIN: 07350002010549, 07350002010679 and 07350002010730; Serial Numbers: 13.0.0.1547, 13.1.0.144 and 13.1.1.89; Expiration Date: 2028-10-05.
- Product
- RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 128 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.
- Recall date
- May 8, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)