Recall Z-0115-2012 ยท MUE Full Field Digital, System, X-Ray, Mammographic
GE Healthcare, LLC
GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. The Senographe DS system generates digital mammographic images, which can be used for screening and diagnosis of breast cancer. The Senographe DS is intended to be used in the same clinical applications as traditional mammographic film/screen systems.
| Date | Oct 26, 2011 (initiated Sep 22, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. |
| Root cause | Software design |
| Action | GE Healthcare sent an " URGENT MEDICAL DEVICE CORRECTION" letter dated September 21, 2011 to all affected customers. The letter describes the products, problem, and actions to be taken by the customers. The letter provides safety instructions and advises customers to complete and return a Customer Reply Form via fax to +33(0)1 30 70 39 30. A GE Healthcare service representative will contact customers if the updated software version is required. Contact the Call Center at 800-437-1171. |
| Quantity | 1344 |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and Washington, D.C. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA,GERMANY, GREECE, GUADELOUPE, GUYA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.