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Recall Observatory FDA recall evidence

Device product

Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255

Z-1192-2023

January 24, 2023

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 91582
Status
Ongoing
Classification
Class II
Quantity
83,185
Official record key
device-enforcement:Z-1192-2023

Official wording

Reason: 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

Code information: 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

Distribution pattern: 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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software/network cards/IP addresses can have network/wireless connection failure. Could cause

Field note

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