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)
FDA Recall Z-1427-2021 · Posted None
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Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusOpen, Classified
Product CodeMUJ
Date Initiated2021-03-25
Product Quantity1 system
Reason for Recall
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Firm Action
On 03/25/2021, RaySearch Laboratories issued an Urgent Medical Device Correction notice via email to their customer notifying them of an issue found with the display of flags in RayTreat. Flags edited in RayCare after a patient has been checked in, may not be updated in RayTreat.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide in the state of TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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