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Recall Observatory FDA recall evidence

Device product

RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)

Z-1427-2021

March 25, 2021

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 87666
Status
Ongoing
Classification
Class II
Quantity
1 system
Official record key
device-enforcement:Z-1427-2021

Official wording

Reason: Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

Code information: Software version: 9A, 9B, 10A, 10B

Distribution pattern: US Nationwide in the state of TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.