RAYSEARCH LABORATORIES AB recalls RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can…
- Recall date
- May 18, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2340-2020
- FDA classification
- Class II
- Brand / firm
- RAYSEARCH LABORATORIES AB
- Sold / distributed
- 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.
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Get recall alerts
Free email alert whenever RAYSEARCH LABORATORIES AB has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: RAYSEARCH LABORATORIES AB