Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical Solutions, Oncology Care System. Intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Recall Z-0857-2009 · Posted 2009-01-14
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-10-23
Date Terminated2010-12-09
Product Quantity31 consignees have the configuration noted above.
Reason for Recall
Under certain conditions, the flat panel may move unexpectedly and collide with the patient.
Firm Action
The firm issued an Urgent Medical Device Customer Safety Letter, dated 10/23/2008. With the letter included a detailed description of the issue, the condition under which this issue may occur, and recommendation to avoid them. Customers are to read the information carefully and distribute to the responsible persons. The Customer Safety Letter should be included their syngo RT Therapist Express manual and remain there until the next release of software is installed. In the interest of safety, the preventive measures should be performed and all affected personnel should be informed immediately. The firm is tracking responses via return cards and completion protocol.
Root Cause
Labeling design
Distribution Pattern
Worldwide Distribution --- including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Belgium, France, New Zealand, 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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