Elekta Unity, Image-Guided Radiation Therapy System
FDA Recall #Z-2473-2020 — Class II — December 18, 2019
Product Description
Elekta Unity, Image-Guided Radiation Therapy System
Reason for Recall
There have been reports of excessive heating in the MRL Gradient Connection Module.
Recalling Firm
Elekta, Inc. — Atlanta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
21 devices
Distribution
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.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated