ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software

FDA device recall Z-2190-2011 · posted 2011-05-12 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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.

Action taken

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

Status

Terminated

Product code

IYE

Quantity affected

228 active devices

Distribution

Worldwide Distribution

Date initiated

2011-03-24

Date posted

2011-05-12

Date terminated

2012-02-13

Location

Concord, CA

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