Elekta Limited: Medical Device Recall in 2019 - (Recall #: Z-1297-2019)

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 systems Product Usage: 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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

Product Classification:

Class II

Date Initiated: April 3, 2019

Date Posted: May 15, 2019

Recall Number: Z-1297-2019

Event ID: 82537

Reason for Recall:

There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.

Status: Terminated

Product Quantity: 9 devices

Code Information:

Product Code: UNITY SYSTEM/13553-006/600003, UNITY SYSTEM/10817-011/600010, 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/11611-40/600011, UNITY SYSTEM/11489-21/600009; UDI: 1536549, 1536549

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated