Apr

2021

Recall – Treatment planning system did not update patient in other modules

Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 4/21/2021
Class II

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)

Recall Number: Z-1427-2021

REASON

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

RECALLING FIRM/MANUFACTURER

RAYSEARCH LABORATORIES AB on 3/25/2021. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1 system

DISTRIBUTION

U.S. Nationwide

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Recall – Treatment planning system did not update patient in other modules

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