FDAFDA · Food and drugs·Recall number Z-0023-2016
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.
Published October 14, 2015 · Recall initiated: September 16, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Images may be missing when a system parameter MapRoute is set to a value greater than 1.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare
- Distributor
- Worldwide Distribution: US (nationwide) including states of: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and countries of: Argentina , Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile , China, Colombia, Costa Rica, Ecuador, Egypt, France, Germany, Great Britain, Hong Kong, Hungary, India, Israel, Italy, Japan,Korea, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Nigeria, Panam¿, Peru, Philippines, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, Venezuela, and Vietnam.
- Lot
- GE Centricity PACS-IW versions 3.5.0 through 3.7.3.9 Sp2, 3.7.3 Spa10, and 4.0.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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