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Recall Observatory FDA recall evidence

Device product

Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633

Z-0210-2025

September 19, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 95409
Status
Ongoing
Classification
Class II
Quantity
6045 units
Official record key
device-enforcement:Z-0210-2025

Official wording

Reason: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.

Code information: a) REF 1604786, UDI/DI 00887761967533; b) REF 1604788, UDI/DI 00887761967526; c) REF 1723633, UDI/DI 00887761967519 ALL SERIAL NUMBERS

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.