FDA-Device2025-03-26Class II
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.
CareFusion 303, Inc.
Hazard
Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.
Sold states
Worldwide - US Nationwide distribution including in the states of KY, OH, NY, MO, NC, PA, FL, TN, CT, LA, MN, VA, MD, CA, TX, NE, IA, OK, MI, PR, SD, IN, ME, KS, IL, NM, WA, AR, HI, MS, GA, WY, WI, VT, AL, NV, NJ, DC, AZ, MT, AK, OR, CO, NH, MA, SC, ID, UT, ND and the countries of TW, CA, AE, MX, SG, AU, NZ, GB, CH, BH.
Affected count
727
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2025Don't want to check this manually?
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