FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: 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
- Recall number
- Z-1579-2023
- 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
- Status
- Open, Classified
- Initiated
- 2023-04-05
- Posted
- 2023-05-11
- Terminated
- not on file
- Reason
- 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 Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.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
- 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 BDRC24@bd.com 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
- 1,474
- Distribution
- US Nationwide distribution in the states of KS, NY, NC, LA, MA, MI.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BRY
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06