FDAClass IIMarch 13, 2024

BD Pyxis: MedStation ES recall: Software Issue

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

Why was BD Pyxis: MedStation ES recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Recalling firm
CareFusion 303, Inc.
Quantity
20,443
Distribution
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.
Recall date
March 13, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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