Recall Z-1063-2012
GE Healthcare, LLC · initiated October 17, 2011
Product
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.
Codes / lots: Core system Serial Number 00000391762BU2 00000325724BU3 00000385184BU7 00000423397BU9 00000329513BU6 00000352470BU9 00000352505BU2 00000462795BU6 00000430405BU1 00000002298472 00000432209BU5 00000367810BU9 00000392487BU5 00000436378BU4 00000425069BU2 00000389899BU6 00000389903BU6 00000423972BU9 00000321228BU9 00000380496BU0 00000401721BU6 00000413937BU4 00000413932BU5 00000478006BU0 00000548790BU5 00000549994BU2 00000492489BU0 00000493445BU1 00000548661BU8 00000341139BU4 00000442937BU9 00000396379BU0 00000415901BU8 00000411771BU9 00000426222BU6 00000341141BU0 00000406709BU6 00000306447BU4 00000396374BU1 00000429238BU1 00000429237BU4 00000464204BU7 00000512135BU5 00000331147BU9 00000549996BU7 00000547683BU3 00000326718BU4 00000453800BU5 00000311474BU1 00000329510BU2 00000315702BU1 00000434150BU9 00000408814BU2 00000405615BU6 00000341140BU2 00000442936BU1 00000478005BU2 00000552037BU4 00000479905BU2 00000553776BU6 00000476598BU8 00000485497BU2 00000379684BU4 00000371585BU1 00000371591BU9 00000374555BU1 00000428299BU2 00000380777BU3 00000380780BU7 00000366076BU8 00000415895BU2 00000351503BU8 00000377508BU7 00000323412BU7 00000343563BU3 00000410071BU5 00000338728BU9 00000348120BU7…
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1063-2012
- Initiated
- October 17, 2011
- Posted by FDA
- February 20, 2012
- Terminated
- March 12, 2014
- Product code
- MUE – Full Field Digital, System, X-Ray, Mammographic
- 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 EMIRATES, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL…
- Recalling firm
- GE Healthcare, LLC, Waukesha, WI