Date Initiated by Firm |
June 24, 2019 |
Date Posted |
July 16, 2019 |
Recall Status1 |
Terminated 3 on April 01, 2021 |
Recall Number |
Z-1980-2019 |
Recall Event ID |
83158 |
510(K)Number |
K182076
|
Product Classification |
Accelerator, linear, medical - Product Code IYE
|
Product |
Elekta Unity, Image-Guided Radiation Therapy System
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. |
Code Information |
UDI/GTIN: 5060081071321 Installed product: UNITY SYSTEM/13553-006/600003 UNITY SYSTEM/10817-011/600010 UNITY SYSTEM/12473-020/600020 UNITY SYSTEM/12274-017/600012 UNITY SYSTEM/10562-011/600016 UNITY SYSTEM/10719-T03001/600013 UNITY SYSTEM/30004070-001/600023 UNITY SYSTEM/10420-AVL-U/600008 UNITY SYSTEM/11014-UMCU-U/600007 UNITY SYSTEM/10157-006/600014 UNITY SYSTEM/11611-40/600011 UNITY SYSTEM/11489-21/600009 |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter NE Ste 50 Atlanta GA 30346-1227
|
For Additional Information Contact |
Alejandra Carrillo 404-202-4333
|
Manufacturer Reason for Recall |
The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
|
FDA Determined Cause 2 |
Software design |
Action |
The firm, Elekta, disseminated their "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" by email on 06/24/2019 to its customers. The notices identified the problem, provided recommended actions, and requested the notice be placed in a place accessible to all users. Customers were also instructed to complete and return the Acknowledgement Form. A software update will be provided once available.
If you have any questions, contact the Post Market Surveillance Specialist by email: Elekta_Global_PMS@elekta.com. |
Quantity in Commerce |
12 units |
Distribution |
US Distribution to states of: TX & WI, and Internationally to: Canada, Denmark, Germany, Italy, Netherlands, Sweden, and the UK. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = Elekta Limited
|