Elekta, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2473-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Elekta Unity, Image-Guided Radiation Therapy System

Product Classification:

Class II

Date Initiated: December 18, 2019

Date Posted: July 8, 2020

Recall Number: Z-2473-2020

Event ID: 85620

Reason for Recall:

There have been reports of excessive heating in the MRL Gradient Connection Module.

Status: Terminated

Product Quantity: 21 devices

Code Information:

Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035

Distribution Pattern:

Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution.

Voluntary or Mandated:

Voluntary: Firm initiated