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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta Precise Linear Accelerator System

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 Class 2 Device Recall Elekta Precise Linear Accelerator Systemsee related information
Date Initiated by FirmJanuary 07, 2015
Date PostedFebruary 10, 2015
Recall Status1 Terminated 3 on April 14, 2016
Recall NumberZ-1088-2015
Recall Event ID 70279
510(K)NumberK051932 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductPrecise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Code Information 153602, 153538, 153561, 153569, 153532, 153556, 153566, 153563, 153564, 153589, 153530, 153531, 153562, 153584, 153615, 153534, 153534, 153535, 153563, 153542, 153542, 153548, 153548, 153558, 153578, 153595, 153699, 153630, 153728, 153680, 153712. 153717, 153723, 153734, 153702, 153715, 153684, 153710, 153577, 153725, 153726, 153691, 153696, 153713, 153724, 153727
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information ContactLinda Wetsel
404-993-5886
Manufacturer Reason
for Recall		Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
FDA Determined
Cause 2		Other
ActionElekta sent an Urgent Important Field Safety Notice on January 7, 2015, to all affected customers. Elekta recommended that customers replace the M20 x 50 MM bolts marked 'OF' on the gantry counterbalance frame immediately. The digital linear accelerator must not be used until these 'OF' bolts are replaced. Elekta recommended that customers put the machine in a parked position at 0, and attach the gantry locking straps. A Modification kit will be available as soon as possible which contains the correct bolts. Customers were instructed to complete the Important Field Safety Notice Acknowledgement form and return to their local Elekta Office or Representative. Customers with questions were instructed to contact their local Elekta representative. For questions regarding this recall call 404-993-5886.
Quantity in Commerce46
DistributionWorldwide Distribution - USA including AZ, CA, FL, KS, LA, MN, MO, NY, NC and Internationally to Austria, Bulgaria, Canada, China, Germany, Hungary, Italy, Malaysia, Malta, Netherlands, Norway, Russia, Spain, Sweden, Taiwan and Ukraine.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYE
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