FDA-Device2024-02-28Class I
Baxter Exactamix Pro 1200, REF EXM12DY
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
8 devices
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter Exactamix Pro 1200, REF EXM12DY
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1001-2024Don't want to check this manually?
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