Elekta, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1980-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 24, 2019

Date Posted: July 24, 2019

Recall Number: Z-1980-2019

Event ID: 83158

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.

Status: Terminated

Product Quantity: 12 units

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

Distribution Pattern:

US Distribution to states of: TX & WI, and Internationally to: Canada, Denmark, Germany, Italy, Netherlands, Sweden, and the UK.

Voluntary or Mandated:

Voluntary: Firm initiated