RayStation 9B Service Pack 1 recall: Software Issue
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer…
Why was RayStation 9B Service Pack 1 recalled?
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 # 07350002010297 Build number: 9.2.0.483
- Product
- RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer…
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- N/A
- Distribution
- US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)