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Recall Observatory FDA recall evidence

Device product

BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;

Z-1223-2024

February 01, 2024

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 93932
Status
Ongoing
Classification
Class II
Quantity
20,443
Official record key
device-enforcement:Z-1223-2024

Official wording

Reason: Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.

Code information: REF/UDI-DI: 323/10885403512667, 327/10885403477836, 352/10885403512674. All Using Software Version ES System Release 1.4.x, 1.5.x and 1.6.x

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of VA, SC, IL, AL, KS, LA, GA, FL, CA, PR, PA, WV, WA, HI, NC, MD, AR, NY, ND, TX, NM, GU, MS, AZ, DC, AK, NE, DE, CO, SD, MO, NJ, OK, NV, OH, KY, WY, MT, UT, ID, MA, MI, MP, NH, IA, TN, CT, RI, IN, WI, OR, MN, VT, ME and the countries of BH, DE, GB, IT, JP, ES, GU, KR, BE, AR, BR, BS, CL, CO, MX, AE, AU, CA, EG, FR, HK, MY, NZ, QA, SA, TH, NL, MC, CH, FI, JO, KW, LB, OM.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in