Recall Z-1207-2023 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.
| Date | Mar 17, 2023 (initiated Feb 14, 2023) |
| Status | Open, Classified |
| Reason | Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications. |
| Root cause | Software change control |
| Action | On 01/14/23, correction notices were mailed to directors of pharmacy informing them to take the following actions: 1) Ensure this letter and contents are forwarded and/or discussed with all appropriate personnel to ensure proper awareness of the issue. 2) If you are experiencing any issues, such as drawer failures, call BD technical support and refer to user guides for additional information and troubleshooting procedures. a. BD Pyxis MedStation ES user guide, refer to sections "Recover storage space" (Chapter 9, pg. 76) and "Emergency medication removal" (Appendix 11, pg. 119). See reference |
| Quantity | 7914 |
| Distribution | Worldwide - US Nationwide distribution including in the states of NY, PA, OH, TX, FL, KY, IL, DE, AK, WI, KS, LA, WA, AZ, CO, MI, IN, TN, SD, AR, MO, CA, NV, MA, SC, VA, WV, CT, ME, NE, RI, GA, NC, IA, MN, AL, OK, MS, NM, NH, VT, WY, OR, ID, NJ, UT, DC, HI, MD, MT, ND and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.