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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta Harmony Pro, Elekta Infinity, and Elekta Versa HD

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  Class 2 Device Recall Elekta Harmony Pro, Elekta Infinity, and Elekta Versa HD see related information
Date Initiated by Firm September 28, 2021
Create Date October 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-0115-2022
Recall Event ID 88771
510(K)Number K210500  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Medical Linear Accelerator (EMLA):

Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Code Information Elekta Harmony Pro, Serial #441009, UDI (01) 05060191071604; Elekta Infinity, Serial #156645, UDI (01) 05060191071543; and Elekta Versa HD, Serial #156646, #156477, and #156648, UDI (01) 05060191071574
Recalling Firm/
Manufacturer		 ELEKTA SOLUTIONS AB
Box 7593
KUNGSTENSGATAN 18
Stockholm Sweden
For Additional Information Contact
855-6935358
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		 Nonconforming Material/Component
Action The recalling firm issued an Urgent Important Field Safety Notification dated September 2021 via email on 9/28/2021. The Subject of the letter was addressed for the service user regarding precautions to be taken when handling diode D1. The notification described the details of the failure and that Elekta is currently working on a solution to eliminate this failure mode. The notice was to be placed in an area accessible to all users until the correction is made. Appropriate personnel who work with this product are to be advised on the content of the letter. Corrective actions were provided regarding removing the modulator covers and the Personal Protective Equipment that must be worn by the engineer, including a safety visor, protective jacket, and gloves. Instructions for removing the RDO diode (D1) were provided. An Acknowledgment Form was included for completion and return to Elekta no later than 30 days for acknowledgement that the service user has read and understands the notification and accepts the implementation of any given recommendation.
Quantity in Commerce 2 in the U.S.
Distribution Distribution was to ND and NC. There was no military/government distribution.
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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