Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the Flat Panel, Part No. 8139789, To deliver x-ray radiation for therapeutic treatment of cancer. Product is manufactured and distributed by Siemens Medical Solutions, Concord, CA
FDA Recall Z-0449-2011 · Posted 2010-11-24
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-01-22
Date Terminated2011-04-12
Product Quantity106
Reason for Recall
The robotic lift armature shaft may break and allow the Flat Panel Positioner with the digital flat panel imager to fall into the Flat Panel cradle. If the positioner is over a patient, there is a potential for injury.
Firm Action
Siemens sent an Urgent Medical Device Correction letter to all on January 27, 2010, via phone, Fax, certified mail and/or delivery via Siemens Customer Service Group to all its direct consignees, informing them of the affected products, the problem, and provided instructions on the recall.
Consigneees were to be contacted by an ARTISTE Service Representative for an appointment for corrective action. Consignees were instructed to include Customer Safety Advisory Notice in their ARTISTE System Owner Manual.
For questions regarding this recall call (925) 246-8407.
Root Cause
Other
Distribution Pattern
Worldwide Distribution - USA including CA, DE, FL, LA, MA, MI, MO, NC, NE, NJ, OH, PA, TN, UT, WI, AND WV and Egypt, Germany, Japan, Lebanon, Malaysia, New Zealand, Poland, Russia, Spain, Sweden, and Turkey
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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