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Recall Observatory FDA recall evidence

Device product

RayStation 11B

Z-1299-2022

June 10, 2022

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 90505
Status
Terminated
Classification
Class II
Quantity
26
Official record key
device-enforcement:Z-1299-2022

Official wording

Reason: This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.

Code information: UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68

Distribution pattern: US Nationwide distribution in the states of NJ and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.