Recall Z-1519-2013 ยท MUE Full Field Digital, System, X-Ray, Mammographic
GE Healthcare, LLC
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.
| Date | Jun 26, 2013 (initiated Jan 14, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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 |
| Quantity | 49 installed in the US. |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.