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
This recall has been terminated (originally issued November 24, 2010).
- Recall Initiated
- January 22, 2010
- Posted
- November 24, 2010
- Terminated
- April 12, 2011
- Recall Number
- Z-0449-2011
- Quantity
- 106
- Firm Location
- Martinez, CA
- Official Source
- View on FDA website ↗
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.
Distribution
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
Lot / Code Info
All units--Dates of manufacture: July 17, 2008 to September 19, 2008.
Root Cause
Other
Action Taken
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.