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Recall Observatory FDA recall evidence

Device product

RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

Z-2349-2020

May 18, 2020

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 85723
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2349-2020

Official wording

Reason: 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.

Code information: UDI # 07350002010174 Build number: 9.0.0.113

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software error