Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed
Reason for recall: Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed Distribution: US: FL, CA, OR, IL, WI, NJ, AZ, NV, CO, WY, NE, TX, MI, VA, OH, NC, LA, NM, AL, TN, AR, PA, CT, IN, KS, GA, SC, MD, UT, MA, DC, OK, IA, NY, WA, SD, ND, MN, KY, MO, WV, MS, DE, ME, MT, ID, NH, HI, AK, VT OUS: Canada, Qatar, Saudi Arabia,, Kuwait, United Arab Emirates, Israel, South Africa, Zimbabwe, Botswana, Australia, New Zealand Quantity: 83,185 Lot/code info: All PC Units, UDI-DI: 10885403801549, 10885403801532, with software versions 12.1.0, 12.1.2, 12.1.3, utilizing affected network cards and IP addresses
10885403801549, 10885403801532
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.