medical Class II Updated 2020-06-17

RAYSEARCH LABORATORIES AB recalls RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usag

Recalled Product

RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Build numbers: 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 5.0.1.11, 5.0.2.35,

View official government recall

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