Recall Z-1418-2025— Baxter Healthcare Corporation

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-02-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086. Reason: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled..

Recalling firm
Baxter Healthcare Corporation
Classification
Class II
Status
Ongoing
Initiated
2025-02-25
Firm location
Deerfield, IL, United States

Product description

Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.