Class 2 Device Recall Elekta Synergy, Elekta Harmony", Elekta Infinity ", Versa HD"

• Date Initiated by Firm: October 25, 2023
• Date Posted: December 01, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0447-2024
• Recall Event ID: 93264
• 510(K)Number: K210500
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
• Code Information: UDI/DI N/A, Serial Numbers: 152140, 152617, 152691, 152004, 152683, 152994, 153935, 152620, 152809, 152854, 152867, 152885, 152964, 152974, 153192, 153217, 153527, 152499, 153668, 152519, 153118, 153102, 153204, 153166, 152017, 152112, 152325, 152749, 152754, 152755, 152756, 152860, 153006, 151874, 152538, 152839, 152921, 153149, 153267, 152736, 151793, 151802, 151812, 151960, 152600, 152678, 152838
• FEI Number: 1037831
• 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: Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
• FDA Determined Cause: Under Investigation by firm
• Action: Elekta released Field Safety Notice to its consignees on the 10/25/2023 via email. The notice explained the issue, potential risk, and provides information for the safe use of the instrument until Elekta Field Service Representatives can perform the correction.
• Quantity in Commerce: 47 units
• Distribution: worldwide
• 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