Agency classClass IIOur severity:High FDA (Devices)·Z-0217-2025·Announced 2024-10-30

Baxter Operating Table TruSystem 7000 U14 Recalled for Battery Short-Circuit Risk

Baxter Healthcare is recalling 542 units of the Operating Table TruSystem 7000 U14 worldwide due to reports of electrical short-circuits and smoke emissions from batteries and connectors.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of critical surgical equipment with an identified risk-of-harm hazard (electrical short-circuits and smoke emissions). No injuries or illnesses are reported in the source text, placing it at severity level 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation is recalling 542 units of the Operating Table TruSystem 7000 U14 (MBW, Product code REF 2065385), which have been distributed worldwide. The recall identification is UDI/DI 00887761968653, and all serial numbers of this model are affected.

The firm received customer reports indicating that the batteries and their electrical connectors experienced electrical short-circuits and/or emitted smoke. These reports prompted this recall action.

Healthcare facilities using this equipment should contact Baxter Healthcare Corporation or the U.S. Food and Drug Administration for guidance on corrective actions, repair, or replacement. Do not use the affected operating tables until corrective action has been taken.

The recalled product

Product: Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Operating Table
Hazard: electrical-short-circuit
fire-risk
Affected units: 542

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI/DI 00887761968653
All Serial Numbers

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 9 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · electrical short circuit