BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
This recall is currently active, issued August 20, 2024. It was issued by Carefusion 303, Inc..
- Company
- Carefusion 303, Inc.
- Recall Initiated
- February 1, 2024
- Posted
- August 20, 2024
- Recall Number
- Z-1223-2024
- Quantity
- 20,443
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
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
Root Cause
Software design
Action Taken
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