ClearanceBrief
Recall Z-2017-2025 ยท BRY Cabinet, Table And Tray, Anesthesia

CareFusion 303, Inc.

Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], 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], MD BD Pyxis SupplyStation V9 [317], Security Module [139698-01], BD Knowledge Portal for Medi

DateJun 24, 2025 (initiated May 8, 2025)
StatusOpen, Classified
ReasonDuring automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
Root causeSoftware Design Change
ActionOn 5/8/2025, correction notices were mailed and emailed to Customers informing them of the following: Firm has temporarily configured impacted devices to "disabled" mode so the device will not automatically apply validated patches intended to address security vulnerabilities or performance issues. Device keys can be used to manually access unavailable drawers and must be readily available and retrievable to constitute risk mitigation; medications can also be obtained from other unaffected dispensing devices or pharmacy. The Pyxis Anesthesia Station unlocks non-secure drawers upon user login
Quantity6,332
DistributionWorldwide - US Nationwide distribution including in the states of PR, DE, GU, MO, IA, IL, CA, MD, MA, VA, PA, NY, WA, NJ, AZ, CO, OH, FL, WI, TX, CT, LA, MI, WY, MN, AR, KY, OR, NM, TN, NC, SC, IN, VT, KS, AL, GA, WV, NV, ID, DC, MS, NE, HI, OK, UT, ND, MT, NH, SD, ME, RI, AK, MP and the countries o
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.