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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta Medical Linear Accelerator (EMLA),

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  Class 2 Device Recall Elekta Medical Linear Accelerator (EMLA), see related information
Date Initiated by Firm September 17, 2021
Create Date October 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-0116-2022
Recall Event ID 88681
510(K)Number K210500  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Medical Linear Accelerator (EMLA), configured as follows:

a. Elekta Precise Digital Accelerator;

b. Elekta Harmony;

c. Elekta Synergy;

d. Elekta Infinity;

e. Versa HD
Code Information a. Elekta Precise Digital Accelerator - UDI GTIN Number: 5060191071017, Model Numbers: XRT 0601 (NFB), XRT 0611 (FB), All Serial Numbers;   b. Elekta Harmony - UDI GTIN Number: 05060191071581, Model Numbers: XRT 2201 (NFB), All Serial Numbers;   c. Elekta Synergy - UDI GTIN Number: 05060191071550, Model Numbers: XRT 0621 (NFB), XRT 0631 (FB), All Serial Numbers;   d. Elekta Infinity - UDI GTIN Number: 05060191071543, 05060191071512, Model Numbers: XRT 0511 (NFB & MLCi2), XRT 0521 (FB & MLCi2), XRT 0531 (NFB & Agility), XRT 0541 (FB & Agility), All Serial Numbers;   e. Versa HD - UDI GTIN Number: 05060191071574, 05060191071529, Model Numbers: XRT 2121 (NFB), XRT 2131 (FB), All Serial Numbers 
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact
770-670-2422
Manufacturer Reason
for Recall		 There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
FDA Determined
Cause 2		 Under Investigation by firm
Action Written notification letter titled, "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" via email on 09/17/2021. The letter instructs consignees to please post the notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. Consignees are to advise the appropriate personnel, working with this product, on the content of the letter. The consignee is requested to submit an acknowledgement form to their local Elekta representative as soon as possible, but no longer than 30 days from receipt.
Quantity in Commerce 4,405 units
Distribution Distributed nationwide to FL, NC, OH, CA, IL, MD, OR, AL, NY, PA, MA, AK, GA, OR, KY, VA, TX, SD, AZ, NJ, MI, WI, ND, MO, WA, OK, PR, NM, NC, ID, CT, DE, LA, MT, TN, CO, UT, MN, IN, RI, IA, DC, ND, AZ, HI, KS, NE, NH, AR, WY, WV, MS, VT and internationally to Albania, Antigua/Barbuda, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kyrgystan, Lao People's Democratic Republic, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestinian Territory, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = Elekta Limited
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