Recall Z-2477-2025 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323 BD Pyxis" CII Safe ES / 10885403512605 / 1116-00 BD Pyxis" Enterprise Server / 10885403518348 and 10885403520341 / 1115-00 BD
| Date | Aug 28, 2025 (initiated May 8, 2025) |
| Status | Open, Classified |
| Reason | Antivirus software was not consistently installed on impacted devices during the implementation process. |
| Root cause | Under Investigation by firm |
| Action | On 05/08/2025, the firm sent via mail and email an "URGENT MEDICAL DEVICE PRODUCT CORRECTION" Letter informing customers of two issues. For this recall the issue pertains to technicians failing to install (ESET) antivirus software on affected devices. This can potentially result in a malicious actor that could exploit a cybersecurity weakness on a device that is configured without antivirus protection within a hospital network. Customer are instructed and/or informed: For Clinical Users: -to utilize user facility policies and procedures for cybersecurity issues or disaster recovery. -to remo |
| Quantity | 8353 devices (6738 U.S. and 1615 O.U.S.) |
| Distribution | Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.