Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is Recalled by Ge Healthcare It Due to Multiple issues were identified with the GE Centricity...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ge Healthcare It directly.
Affected Products
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.
Quantity: 847 units
Why Was This Recalled?
Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe
Where Was This Sold?
This product was distributed to 48 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY
About Ge Healthcare It
Ge Healthcare It has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report