Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.
FDA Recall Z-0116-2009 · Posted 2008-10-20
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-07-04
Date Terminated2010-12-22
Product Quantity16
Reason for Recall
Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images.
Firm Action
A letter marked "Urgent" dated July 4, 2008 was sent to customers. The letter provided a detailed description of the issues, the conditions under which these issues may occur, as well as recommendations to avoid these issues. Customer notification TH022/08/S was released on July 11, 2008. A software fix is currently being validated. All consignees notified by certified mail. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for assistance.
Root Cause
Software change control
Distribution Pattern
Nationwide in LA, WI, DE, PA and OH, and internationally in Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium and France
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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