—#99298

Product

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

FDA product code: IWE — Monitor, Patient Position, Light-Beam
Device class: Class 1
Medical specialty: Radiology
Affected lot / code info: Part # 5417918-1EN.

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2011-01-26
Posted by FDA: 2011-07-21
Terminated: 2012-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99298. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.