RayCare 2024A SP4. Oncology Information Systems.
FDA Recall Z-2647-2026 · Posted 2026-07-01
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Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusOpen, Classified
Product CodeMUJ
Date Initiated2026-05-20
Product Quantity3 units
Reason for Recall
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Firm Action
A Field Safety Notice, Medical Device Correction #175428 dated 6/2/26 was emailed to consignees. The notice advises consignees to ensure clear verbal or procedural communication when updating the beam set delivery note, avoid making changes from any location other than the control room when treatment is ongoing, avoid relying on beam set delivery note for conveying critical information. Additionally, consignees are to ensure planning staff and users are educated of the provided workaround. Consignees are to verify the software version of their units and reply to the emailed notification. A software update is scheduled for August 2026 to address this issue. Consignees with questions can contact [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - US Nationwide distribution.
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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