Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.
FDA Recall Z-0927-2009 · Posted 2009-01-29
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-10-23
Date Terminated2010-12-09
Product Quantity36 units
Reason for Recall
If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstanc
Firm Action
An Urgent Medical Device Customer Safety Letter dated October 23, 2008 was issued to consignees via certified mail. The letter identified the issue and preventive measures for consignees. Monitoring will be done via return cards. Follow-up to be conducted via telephone.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium, New Zealand, France, Malaysia, Spain, and Canada.
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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