FDA recall Z-2341-2020

Product

RayStation 6, UDI # 07350002010013 - 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-2341-2020