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Recall Observatory FDA recall evidence

Device product

BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units

Z-2262-2024

May 21, 2024

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 94718
Status
Ongoing
Classification
Class II
Quantity
168 software version
Official record key
device-enforcement:Z-2262-2024

Official wording

Reason: Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.

Code information: UDI: 10885403960123/ Software versions 12.5.1

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue