GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D system generates digital m
FDA device recall Z-1063-2012 · posted 2012-02-20 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MUE
- Quantity affected
- 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
- Date initiated
- 2011-10-17
- Date posted
- 2012-02-20
- Date terminated
- 2014-03-12
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.