Recall Z-1063-2012 ยท MUE Full Field Digital, System, X-Ray, Mammographic
GE Healthcare, LLC
GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D system generates digital mammographic 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 mammographic film/screen systems.
| Date | Feb 20, 2012 (initiated Oct 17, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of inaccurate measurements on GE magnified images provided by Senographe 2000D Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. |
| Root cause | Device Design |
| Action | GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 17, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Contact the Call Center at 800-437-1171 for questions regarding this notice. |
| Quantity | 1060 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, AZ, AR, CA,CT, DC,FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WV,and WI and countries of VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRAT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.