FDA recall Z-2348-2020

RAYSEARCH LABORATORIES AB · Class II · device

Product

RayStation 8B Service Pack 2, UDI # 07350002010235 - 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

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.

Key facts

Status
Terminated
Initiation date
2020-05-18
Report date
2020-06-17
Termination date
2021-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2348-2020