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Recall Observatory FDA recall evidence

Device product

Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087

Z-1419-2025

February 25, 2025

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 96286
Status
Ongoing
Classification
Class II
Quantity
93 units
Official record key
device-enforcement:Z-1419-2025

Official wording

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

Code information: UID/DI 00887761974067, All serial numbers manufactured until 11/14/2024.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue