FDA Device

GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system

Hazard

GE Healthcare has become aware of a missing laser aperture warning label (i.e. Laser Aperture - Do Not Stare Into Beam) affecting certain Discovery Systems.

What You Should Do

Remedy

GE Healthcare will bring affected systems into compliance. A GE Healthcare Service Representative will provide a product label correction to address this issue. This will be carried out via a Field Modification Instruction (FMVI 408311 planned to be released in June 2011 with an estimated completion date of August 2011. For questions call 262-513-4122.

Products

GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system
Brand
GE Healthcare, LLC
UPC
Part # 5417918-1EN.

Units Affected

4