—#205949

Product

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

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Software design

Action the firm took

On 2/1/24, correction notices were mailed or emailed to customers and distributors who were told the following: Devices with a random application hang, freeze and/or crashing can be resolved with a reboot of the device. In downtime scenarios, medications can be obtained from other devices or from pharmacy. There are also keys that can be used to manually access contents within the device. 1) Ensure you continue to manually reboot your devices as a part of your maintenance schedule. 2. Disseminate this notification within your facility network to ensure they are aware of the issue. 3. If you experience this issue, please contact Technical Support. 4. Complete the Customer Response Form and return to BDRC53@bd.com If you require further assistance, please contact the firm: Customer Support: 1-866-583-8783, 5:00am PST to 4:00pm PST (8:00am ET to 7:00pm ET), Monday - Friday. Technical Support: bd.com/self-service, 1-800-727-6102, 24 hours, 7 days a week

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

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.

Timeline

Recall initiated: 2024-02-01
Posted by FDA: 2024-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205949. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.