FDA recall Z-2502-2021

GE Healthcare, LLC · Class II · device

Product

Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.

Reason for recall

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

Distribution

AK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV and WY. Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom and Uruguay.

Key facts

Status
Ongoing
Initiation date
2021-08-06
Report date
2021-09-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2502-2021