FDA Recall: Software Issue May Not Connect to Server

Company: CareFusion 303, Inc.
Date of Enforcement Report: 7/3/2024
Class II

PRODUCT

BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units

Recall Number:

Z-2262-2024

REASON:

Due to a software issue there is the potential that the PC unit may not connect to the server which could impact wireless data transmission to and from the server.

RECALLING FIRM/MANUFACTURER:

CareFusion 303, Inc.

VOLUME OF PRODUCT IN COMMERCE:

168 software version

DISTRIBUTION:

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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