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Recall Observatory FDA recall evidence

Device product

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.

Z-1375-2025

February 06, 2025

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 96202
Status
Ongoing
Classification
Class II
Quantity
727
Official record key
device-enforcement:Z-1375-2025

Official wording

Reason: 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.

Code information: BD Pyxis Enterprise Server software versions: 1.7.4.128, 1.7.4.134, 1.7.4.136, 1.7.4.137, All 1.7.1, All 1.7.2, All 1.7.3. REF/UDI-DI: 327/10885403477836, 323/10885403512667, 352/10885403512674, 1116-00/10885403512605

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software error