—#93277

Product

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 product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072485
Affected lot / code info: All units--Dates of manufacture: July 17, 2008 to September 19, 2008.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 757 Arnold Dr, Ste A, Martinez, California 94553-3615

Distribution

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

Timeline

Recall initiated: 2010-01-22
Posted by FDA: 2010-11-24
Terminated: 2011-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93277. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.