Elekta, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Elekta, Inc. is recalling Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging due to 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 independen. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
TX, WI
Page updated: Jan 10, 2026