GE Healthcare, LLC GE Healthcare IDI Mammo Workstation Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare IDI Mammo Workstation
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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GE Healthcare, LLC is recalling GE Healthcare IDI Mammo Workstation due to The measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography sys. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiver, this could lead to an overestimate of the size of the breast lesion that may impact patient treatment and safety. The measurement values for GE images are not affected.
Recommended Action
Per FDA guidance
GE Healthcare issued "Urgent Medical Device Correction" letters dated August 28, 2009 or August 31, 2009 to either Seno Advantage Customers (Hospital Administrators/Risk Mangers, Radiology Department Managers), and Image Diagnostic Customers (Hospital Administrators/Risk Managers, Radiology Department Managers). The letters described the Safety Issue, Affected Product Details, safety Instructions, Product correction and Contact Information. GE will linstall new software with the release of Field Modification Instruction 12129. Customers can contact GE Healthcare about this issue at 800-437-1171.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, PR
Page updated: Jan 10, 2026