FDA-Device2013-07-03Class II
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.
GE Healthcare, LLC
Hazard
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.
Sold states
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.
Affected count
49 installed in the US.
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1519-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief