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Recall Observatory FDA recall evidence

Device product

BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.

Z-1207-2023

February 14, 2023

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 91341
Status
Ongoing
Classification
Class II
Quantity
7914
Official record key
device-enforcement:Z-1207-2023

Official wording

Reason: Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications.

Code information: REF/UDI-DI: 327/10885403477836, 323/10885403512667, 352/10885403512674

Distribution pattern: Worldwide - US Nationwide distribution including in the states of NY, PA, OH, TX, FL, KY, IL, DE, AK, WI, KS, LA, WA, AZ, CO, MI, IN, TN, SD, AR, MO, CA, NV, MA, SC, VA, WV, CT, ME, NE, RI, GA, NC, IA, MN, AL, OK, MS, NM, NH, VT, WY, OR, ID, NJ, UT, DC, HI, MD, MT, ND and the country of Canada.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    firmware may