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Terminated

RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A

FDA Recall Z-0679-2019 · Posted None

Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2018-11-12
Date Terminated2020-04-17
Product Quantity69

Reason for Recall

Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.

Firm Action

RayStation issued Field Safety Notice, Medical Device Correction #37483, on 11/12/18 via email, states issue, action to be taken and correction of software in Dec 2018.

Root Cause

Under Investigation by firm

Distribution Pattern

AZ CA CO CT DE FL GA HI ID IL LA MA MD ME MI MO MS NC NJ NY OH OR PA RI TN TX VA VT WA WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180379RayStation 7RaySearch Laboratories AB (PUBL) · 2018-04-25

Official Source

View FDA Recall →

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

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