RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy recall
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Why was RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy 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: 0735000201031020201216 and 0735000201047120220128; GTIN: 07350002010310 and 07350002010471; Serial Numbers: 10.1.0.613 and 10.1.1.54; Expiration Date: 2027-02-01.
- Product
- RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 18 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)