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U.S. Department of Health and Human Services

Class 2 Device Recall BD Pyxis" MedStation" ES; BD Pyxis" MedStation" ES Tower; BD Pyxis" Anesthesia Station ES

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 Class 2 Device Recall BD Pyxis" MedStation" ES; BD Pyxis" MedStation" ES Tower; BD Pyxis" Anesthesia Station ESsee related information
Date Initiated by FirmFebruary 01, 2024
Date PostedAugust 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1223-2024
Recall Event ID 93932
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductBD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
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
FEI Number 2016493
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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
Quantity in Commerce20,443
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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