RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
FDA Recall Z-1281-2021 · Posted None
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Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusOpen, Classified
Product CodeMUJ
Date Initiated2021-03-03
Product Quantity1 unit
Reason for Recall
Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
Firm Action
Raysearch issued via E-mail on 03 March 2021, Field Safety Notice, Medical Device Correction #75198 letter stating reason for recall, health risk and action to take:
RaySearch will check if the issue affects your system and apply the below solution.
" Until the solution has been applied, be aware that the message body is missing from messages created in RayCare 2.
" Confirm you have read and understood this notice by replying to the notification email.
For regulatory information, please contact [email protected]
SOLUTION
This issue will be resolved by RaySearch staff using a support tool. Using the support tool, the message body will be restored to all messages in the currently used RayCare version.
Root Cause
Software design
Distribution Pattern
US Nationwide distribution 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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