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Class 2 Device Recall Elekta Medical Linear Accelerator (ELMA) |
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Date Initiated by Firm |
May 05, 2023 |
Date Posted |
May 30, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1665-2023 |
Recall Event ID |
92270 |
510(K)Number |
K210500
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Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product |
Elekta Medical Linear Accelerator (ELMA) included in the below platforms:
a. Elekta Infinity; b. Versa HD; c. Elekta Synergy |
Code Information |
Varex Part Number 95510354H-01 (Varex serial numbers 354-01H_A0010004PC to 354-01H_A0010269PC).
a. Elekta Infinity: UDI-DI Number: 05060191071543, 05060191071512 (Serial Numbers: 156073, 152223, 153681);
b. Versa HD: UDI-DI Number: 05060191071574, 05060191071529 (Serial Numbers: 156941, 156989, 156724, 156998);
c. Elekta Synergy: UDI-DI Number: 05060191071550, 05060191071505 (Serial Number: 152483)
Additional serial numbers distributed OUS: 109331, 109333, 109335, 109336, 109339, 109341, 109342, 151879, 152194, 153038, 153299, 153410, 153970, 156841, 156849, 156966, 156968, 156969, 156970, 156971, 156973, 156977, 156978, 156979, 156980, 156981, 156982, 156983, 156984, 156985, 156986, 156987, 156988, 156990, 156992, 156995, 156996, 156997. |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter NE Ste 50 Atlanta GA 30346-1227
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For Additional Information Contact |
770-670-2422
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Manufacturer Reason for Recall |
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Elekta notified customers, via email, on 05/05/2023. Customers were instructed that Elekta will contact each impacted customer to perform an onsite inspection of the power supply unit and replace as needed. Customers were asked to complete and return the Acknowledgement Form. |
Quantity in Commerce |
46 units |
Distribution |
Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain.
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Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = Elekta Limited
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