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U.S. Department of Health and Human Services

Class 2 Device Recall PRIMUS, ONCOR, ARTISTE Linac systems

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  Class 2 Device Recall PRIMUS, ONCOR, ARTISTE Linac systems see related information
Date Initiated by Firm July 18, 2013
Date Posted August 26, 2013
Recall Status1 Terminated 3 on November 24, 2014
Recall Number Z-2095-2013
Recall Event ID 65848
510(K)Number K993425  
Product Classification Accelerator, linear, medical - Product Code IYE
Product PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083.

Product Usage: The intended use of the SIEMENS branded, ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Code Information ONCOR, PRIMUS and ARTISTE Lican systems with tabletop component: Tabletop, 550TxT, TT-A 08632296* Tabletop, 550TxT, TT-S 10046140 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
757 Arnold Dr Ste A
Martinez CA 94553-3615
For Additional Information Contact Christine Dunbar
925-602-8008
Manufacturer Reason
for Recall		 Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, the screws holding the side rails in position on the tabletop might break off.
FDA Determined
Cause 2		 Device Design
Action Siemens released Updated Instruction containing the Medical Device Correction Field Safety Notice of Improvement letter, which was delivered by the Siemens Customer Service Group to all affected customers. The release of this UI TH002/12/S to distribute the update instruction began on July 18, 2013. This document includes completion protocol, which will be completed at each facility and returned to Siemens. A copy of the notification should be kept in the Digital Linear Accelerator System owners manual under Safety Advisory letters. UPDATE: a secnd update intruction, TH003/12/S has been released to begin the replcement of tabletops identified through the inspection carried out through TH002/12/S.
Quantity in Commerce 179 active devices.
Distribution Worldwide Distribution - USA Nationwide in the states of NJ, IN, PA, FL, OH, MN, MO, CA, AL, NE MI, LA. and countries of:Argentina, China, South Africa, Pakistan, Spain, Switzerland, Italy, Algeria, Croatia, Turkey, Canada, Germany, France, Poland, Japan, Russian Federation. Lebanon, Egypt, Slovakia, Latvia, Kenya, Brazil, Kuwait, Saudi Arabia, Greece, Belgium, Taiwan, Portugal.
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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