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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Digital Linear Acceletators

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  Class 2 Device Recall Siemens Digital Linear Acceletators see related information
Date Initiated by Firm May 28, 2014
Date Posted August 10, 2014
Recall Status1 Terminated 3 on July 23, 2015
Recall Number Z-2174-2014
Recall Event ID 68507
510(K)Number K072485  K031764  K982502  K790688  
Product Classification Accelerator, linear, medical charged-particle radiation therapy system - Product Code IYE
Product Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
Code Information material numbers: 01940035, 04504200, 05672977, 05693908, 05857912, 05857920, 08139789, 08319758, 08490005, 08515520, 09401654, 09401746, 09822693, with serial numbers below 3094.
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
FDA Determined
Cause 2
Use error
Action An Urgent Medical Device Correction Field Safety Notice Letter was sent to end users on/about June 2014 which described the product, problem, and actions to be taken to avoid encountering the safety risk to patients and users.
Quantity in Commerce 160
Distribution Nationwide and ROW, including Canada and Mexico.
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 LABORATORIES, INC.
510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.