FDA-Device2024-02-28Class I

Baxter Exactamix Pro 2400, REF EXM24DY

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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