medical Class II Updated 2020-07-08

Elekta, Inc. recalls Elekta Unity, Image-Guided Radiation Therapy System

Recalled Product

Elekta Unity, Image-Guided Radiation Therapy System


Hazard / Issue

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

Issued by

FDA

Affected States: PA, NY, IA
Lot/Code Info: 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
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