medical Class II Updated 2019-08-21

Elekta, Inc. recalls iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2

Recalled Product

iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2


Hazard / Issue

Potential for iGUIDE to incorrectly monitor the 3D position.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Version 2.2.0, Product Code/GTIN Number: 04056719001704; Version 2.2.1, Product Code/GTIN Number: 04056719001742; Version 2.2.2, Product Code/GTIN Number: 04056719002039
View official government recall

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