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Terminated

RayStation 11B

FDA Recall Z-1299-2022 · Posted None

Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2022-06-10
Date Terminated2024-06-11
Product Quantity26

Reason for Recall

This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.

Firm Action

The firm notified customers of the recall via email on June 10, 2022. The notice was titled "Field Safety Notice, Medical Device Correction #99834." Customers were given precautions and instructed on a workaround. The issue will be resolved in the next version of RayStation, scheduled for market release in June 2022, though this may be subject to market clearance.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of NJ and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K220141RayStation 11BRaySearch Laboratories AB (PUBL) · 2022-04-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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