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 other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.