Z-2349-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- May 18, 2020
- Termination Date
- August 6, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
UDI # 07350002010174 Build number: 9.0.0.113