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Recall Observatory FDA recall evidence

Device 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

Z-1579-2023

April 05, 2023

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 92061
Status
Ongoing
Classification
Class II
Quantity
1,474
Official record key
device-enforcement:Z-1579-2023

Official wording

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 Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.

Code information: 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

Distribution pattern: US Nationwide distribution in the states of KS, NY, NC, LA, MA, MI.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software is experiencing: 1) ES device download failure