RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
FDA Recall Z-2899-2020 · Posted None
Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusOpen, Classified
Product CodeMUJ
Date Initiated2020-07-29
Reason for Recall
When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.
Firm Action
Only 1 effected consignee who was emailed a field safety notice on 08/05/2020. This letter instructs the user to:
Be aware that registration of a treatment image with a corresponding study with multiple series in the same frame of reference might block the offline image review. Verify the correctness of the data in RayCare PACS before using the data for any decision making.
-Please educate staff and all users about this workaround.
-Inspect your product and identify all installed units with the above software version number(s).
-Confirm you have read and understood this notice by replying to the notification email.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution including in the state of Tennessee.
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.