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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Apex Add-on microMLC		see related information
Date Posted February 26, 2013
Recall Number Z-0885-2013
Product Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Code Information 152652
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta, Georgia 30346-1227
For Additional Information Contact Linda Wetsel
770-300-9725
Reason for
Recall		 If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
Action Elekta sent an Important Field Safety Notice Field Safety Notice FCO Ref: 20001407029 "Important information for the safe and satisfactory operation of Apex" to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to obey all the applicable instructions, warning, and cautions in the user documentation for each piece of equipment. For questions regarding this recall call 770-300-9725.
Quantity in Commerce 1
Distribution Nationwide Distribution including TX
 
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