Z-1207-2023Class II

BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis...

Name: Z-1207-2023 BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis...
Creator: CareFusion 303, Inc.
Published: 2023-02-14
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2023-02-14 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of 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... on 2023-02-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1207-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-14
Posted: 2023-03-17
Recalling firm: CareFusion 303, Inc
Product: 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.
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: 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 tag: software
FDA 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 references 1 and 2 below for additional details. b. BD Pyxis PAS ES user guide, refer to sections "Emergency access procedures" (Appendix A, pg. 77) and "Storage spaces are not responsive" (Appendix B, pg. 81). See references 3 and 4 below for additional details. 3) Complete and return the Customer Response Form. The firm will take the following actions: 1) All customers who may have affected devices will be notified. 2) Upon receipt of completed response forms, the firm will coordinate the firmware upgrade with customers. Technical Support: 1-800-727-6102, Phone hours: 24 hours, 7 days a week
Quantity in commerce: 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.
Product codes and lots: REF/UDI-DI: 327/10885403477836, 323/10885403512667, 352/10885403512674

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1207-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1207-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-17

Product code BRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)