Z-1579-2023Class II

BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD...

Name: Z-1579-2023 BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD...
Creator: CareFusion 303, Inc.
Published: 2023-04-05
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2023-04-05 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII... on 2023-04-05. FDA classified it as Class II and gives the reason as "Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload...". 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-1579-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-05
Posted: 2023-05-11
Recalling firm: CareFusion 303, Inc
Product: BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload processing error. Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.
Root cause tag: software
FDA root cause: Software Design Change
Action: On 4/5/23, correction notices were distributed to Biomedical Engineering, Risk Management, Nursing, Pharmacy Directors who were informed of the following: 1) Remind users that automated dispensing cabinet devices are not a replacement for the medical record (e.g., medication orders, medication administration record (MAR), and patient allergy information) and are not to be relied on as the source of truth for medication administration. Consult the hospital medical record before removing any medication. 2. Please ensure this letter is forwarded to applicable facilities if devices have been transferred and that all appropriate personnel have been made aware of this issue. 3. Complete and return the response form to [email protected] Recalling Firm Actions: 1. For customers who have reported an upload processing failure, the support team can provide a copy of affected data that is unable to be moved to the ES Server data repository. 2. A software update is available. The recalling firm will contact you to schedule a time to install the software update. For further assistance contact Customer Support at 1-866-583-8783, 5:00am PST to 4:00pm PST, Monday - Friday; or Technical Support, bd.com/self-service, 1-800-727-6102, 24 hours, 7 days a week
Quantity in commerce: 1,474
Distribution: US Nationwide distribution in the states of KS, NY, NC, LA, MA, MI.
Product codes and lots: REF/UDI-DI/Software: 323/10885403512667/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 352/10885403512674/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 327/10885403477836/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 1116-00/10885403512605/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 107-255-01/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1579-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1579-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-11

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)