FDA-Device2024-02-28Class I

Baxter Exactamix Pro 2400, REF EXM24DY

Baxter Healthcare Corporation
Hazard

An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.

Sold states
US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,
Affected count
67 devices
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter Exactamix Pro 2400, REF EXM24DY

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1002-2024

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