FDA-Device2025-03-12Class I

Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

Baxter Healthcare Corporation
Hazard

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

Sold states
US: Nationwide
Affected count
66 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1253-2025

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