Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | GE 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 |
| Product | 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-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis. |
| Quantity | 188 |
| Distribution | Worldwide 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, MALAYSIA, KOREA, JAPAN, ITALY, HUNGARY, GREECE, GERMANY, FRANCE, CHINA, CANADA, BRAZIL, AUSTRIA and ALGER… |
| Initiated | 2012-05-24 |
| Classified | 2012-10-19 |
| Terminated | 2013-03-26 |
| Recall number | Z-0095-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-0095-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/61603/
Alerts for GE HealthCare Technologies Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.