Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Reason for recall: Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK,AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Bermuda, and Canada. Quantity: 2,079 systems Lot/code info: Catalog Number: 1115-00 Software Versions: UDI-DI code for Hardware: 10885403518348 UDI-DI code for Software: 10885403520341 System Versions 1.6.1 - 1.11.0 Server Application Versions ES 4.13 - 5.8.X
10885403518348, 10885403520341
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.