—#118713

Product

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.

FDA product code: MUE — Full Field Digital, System, X-Ray, Mammographic
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Models 5144816-10 rev 2, 3 or 6 and 5144816-10-LE rev1.

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE Healthcare will notify customers with affected systems via letter and enclose a new CD- Rom, along with notification that a GE Representative will schedule an appointment to install the User's Manual along with a GE Service Engineer will go on site to install it on the control station of the Senograph Essential system. 16- H LA 6. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter. GE Healthcare will secure and summarize documentation that the manual has been installed and is available on each affected system and provide summarize of the documentation to the district recall coordinator. For further questions please call ( 262 ) 513-4122.

Recalling firm

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

Distribution

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.

Timeline

Recall initiated: 2013-01-14
Posted by FDA: 2013-06-26
Terminated: 2013-11-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118713. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.