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U.S. Department of Health and Human Services

Class 2 Device Recall ARTISTE Linear Accelerator

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  Class 2 Device Recall ARTISTE Linear Accelerator see related information
Date Initiated by Firm January 22, 2010
Date Posted November 24, 2010
Recall Status1 Terminated 3 on April 12, 2011
Recall Number Z-0449-2011
Recall Event ID 56345
510(K)Number K072485  
Product Classification Accelerator, linear, medical - Product Code IYE
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
Code Information All units--Dates of manufacture: July 17, 2008 to September 19, 2008.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
757 Arnold Dr Ste A
Martinez CA 94553-3615
For Additional Information Contact Christine Dunbar
925-602-8157
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 106
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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