Recall Z-2374-2024 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01
| Date | Jul 17, 2024 (initiated May 2, 2024) |
| Status | Open, Classified |
| Reason | If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication. |
| Root cause | Software change control |
| Action | On 6/6/24, correction notices were distributed to customers who were informed that their devices had been remediated. That they had been contacted by phone in May 2024 to schedule device remediation. The firm re-configured the component manager from "installed mode" to "disabled mode" and checked if the Microsoft patch was present on each device. If the patch was identified on a device, it was removed. All devices were then configured to "managed mode" and rebooted to enable the system appropriately. Customers are asked to complete and return the response form to Email BDRC15@bd.com For safe |
| Quantity | 326 |
| Distribution | Worldwide - US Nationwide distribution including in the states of OR, KS, NE, LA, ND, OK, AL, AK, WI, WV, WA, NV, PR, TX, CO, OH, CA, MO, IA, AZ, IN, AR, IL, MN, HI, NM, FL, SD, UT, NY, VA, GA, MA, NC and the countries of TW, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.