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

FDA device recall Z-1223-2024 · posted 2024-08-20 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

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.

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

Root cause

Software design

Status

Open, Classified

Product code

BRY

Quantity affected

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, M

Date initiated

2024-02-01

Date posted

2024-08-20

Location

San Diego, CA