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U.S. Department of Health and Human Services

Class 2 Device Recall Synergy XVI

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  Class 2 Device Recall Synergy XVI see related information
Date Initiated by Firm April 23, 2014
Date Posted June 16, 2014
Recall Status1 Terminated 3 on July 17, 2017
Recall Number Z-1724-2014
Recall Event ID 68255
Product Classification Accelerator, linear, medical - Product Code IYE
Product Synergy XVI

Intended for radiation therapy treatment.
Code Information XVI R4.0 to R4.2.1, R4.5.0, R4.5.1, and R5.0.0 to R5.0.1
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Ms. Linda Wetsel
770-670-2422
Manufacturer Reason
for Recall		 XVI can incorrectly calculate the target position of the treatment table.
FDA Determined
Cause 2		 Software design
Action Elekta is responsible for the correction of all products with this defect. 1. Notifications regarding the possibility of this software error and subsequent table location error and potential hazards have been sent out. The notifications include steps to take to reduce the possibility of the occurrence of an injury. 2. A software correction has been released for some versions of the XVI software. All versions of software with this error will be corrected by the end of July 2014. 3. The software correction will enable verification that values have been assigned to table position parameters; failure to pass verification will inhibit the system. The software correction will also detect internal communication errors (incomplete registrations) and inhibit the system when those errors are detected. 4. The update will be mandatory and will be made at no cost to the users. CDRH approves this CAP. You may proceed with implementation of the CAP. For further questions please call (770) 670-2422.
Quantity in Commerce 380 US
Distribution Worldwide Distribution - USA including the states of AZ, CT, IA, OH, MD, MI, MN, NV, TX and VA., and the countries of India, Ireland, Malta, Netherlands, South Africa and UK.
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.
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