ClearanceBrief
Recall Z-0095-2013 ยท LLZ System, Image Processing, Radiological

GE Healthcare, LLC

GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resol

DateOct 19, 2012 (initiated May 24, 2012)
StatusTerminated
ReasonGE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv
Root causeSoftware design
ActionGE Healthcare sent a Urgent Medical Device Correction letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will install new software to correct this issue with the release of Field Modification Instruction (FMI) 12129 in the near future. This correction will not affect the performance or any other functionality of your current equipment. A GE Healthcare service representative will contact you to arrange for this modification. This activity will be performed at no cost to you. If
Quantity188
DistributionWorldwide Distribution--USA (nationwide) including the states of CA, CO, CT, DC, FL, GA, KY,LA, MA, MO, NV, NJ, NY, NC, OH, OK, PA, SD, TN, TX, VA and WI., and the countries of UNITED KINGDOM, TUKEY, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL, NEW ZEALAND, NETHERLANDS, MEXICO, MALAY
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K033400SENO ADVANTAGE
Ge Medical Systems W-400, Dec 4, 2003