FDA recall Z-1421-2025

Baxter Healthcare Corporation · Class II · device

Product

Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886

Reason for recall

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-02-25
Report date
2025-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1421-2025