ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software. Siemens Healthcare, Concord, CA. The intended use is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall Z-2190-2011 · Posted 2011-05-12
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-03-24
Date Terminated2012-02-13
Product Quantity228 active devices
Reason for Recall
When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.
Firm Action
Distribution of the Urgent: Medical Device Correction Customer Advisory Notice began on March 24, 2011 via certified mail or by the Siemens Customer Service Group. The letter identified the issue and when it occurs. Users were asked to verify the isocenter position of the reference image in the Portal Review application before using a reference image imported from the treatment planning system. Siemens is currently working on a solution and will notify customers as soon as the update is available. The letter should be included with the Owner Manual of the system in the chapter for "Safety Advisory Letters" until an update is provided.
Root Cause
Pending
Distribution Pattern
Worldwide 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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