Device Recall GE Healthcare Senographe Essential System

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

Radiology Devices

2

No

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.

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.