FDA recall Z-1422-2025

Baxter Healthcare Corporation · Class II · device

Product

Baxter TruSystem 7500, Product Code 4091000

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-1422-2025