GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems.

Reason: GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential.

Code information: Models 5144816-10 rev 2, 3 or 6 and 5144816-10-LE rev1.

Distribution pattern: Nationwide Distribution including the states of NJ, CO, LA, AL, OH, MA, NC, ME, WI, GA, PA, TX, IN, NY, MO, KY, KS, CA, MN, FL and IL.