Class 2 Device Recall Elekta Unity

• Date Initiated by Firm: April 06, 2023
• Date Posted: June 02, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1675-2023
• Recall Event ID: 92053
• 510(K)Number: K212114
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
• Code Information: UDI GTIN 05060191071598, serial numbers: 14117-007/600034, 10632-010/600036, 10817-011/600010, 10905-008/600037, 11198-010/600047, 11198-011/600048, 11830-010/600064, 11888-004/600072, 12108-007/600019, 13371-002/600021, 13553-006/600003, 30003193-003/600074, 13120-017/600073, 11328-019/600059, 14232-001/600095, 12269-004/600100, 11008-003/600104, 13212-007/600106
• FEI Number: 1037831
• Recalling Firm/ Manufacturer: Elekta, Inc.; 400 Perimeter Center Ter NE Ste 50; Atlanta GA 30346-1227
• For Additional Information Contact: 468425400
• Manufacturer Reason for Recall: There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
• FDA Determined Cause: Process design
• Action: The recalling firm issued the Field Safety Notice dated March 2023 via email on 4/6/2023 describing the problem, the clinical impact, and the recommended user action, which is that no actions are required to be taken by the user. The Unity system is safe for clinical use without restriction. The consignee is informed the letter is to notify them there will be action taken on the Elekta Unity system to further reduce the potential risk of overheating within the MR Gradient Coil which could lead to system downtime. The letter is to be posted in a place accessible to all users and appropriate personnel are to be advised on the content of the letter. The letter contains Elekta Corrective Actions, which says the update will be provided via Elekta's Field Change Order process once available and that their local Elekta service representative will contact the consignee to arrange for this activity to be completed. An acknowledgement Form was enclosed to be returned to Elekta immediately upon receipt but no later than within 30 days. The device serial number and location or site of the device is to be reported and the consignee is to sign it to acknowledge they have read and understand the notice and accept the implementation of any given recommendation. UPDATED 12-JUN-23 An updated Important Field Safety Notification was released to customers by email in which supersedes the previous Notice under ref: 200-01-801-012 released on 06-APR-23. The new FSN includes additional information under Recommended User Action.
• Quantity in Commerce: 18 devices
• Distribution: US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.
• 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