Agency classClass IIOur severity:High FDA (Devices)·Z-0210-2025·Announced 2024-10-30

Baxter TruSystem 7000 Operating Tables: Battery Short-Circuits, Smoke Risk

Baxter Healthcare is recalling 6,045 TruSystem 7000 U operating tables worldwide due to battery and connector failures that can cause electrical short-circuits and emit smoke.

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: Class II recall of medical device presenting risk of electrical hazard from battery and connector failures that can cause short-circuits and smoke emission. Risk-of-harm product without reported injuries to date.

Plain-English summary

Baxter Healthcare Corporation is recalling 6,045 units of the TruSystem 7000 U (MB) operating table distributed worldwide. The affected units include product codes REF 1604786, REF 1604788, and REF 1723633.

The firm received customer reports stating that the batteries and their connectors can experience electrical short-circuits and/or emit smoke during operation.

Healthcare facilities using these operating tables should contact Baxter Healthcare Corporation for additional information regarding this recall.

The recalled product

Product: Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Surgical Equipment
Hazard: electrical-short-circuit
smoke-emission
fire-hazard
Affected units: 6,045

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 (6)

a) REF 1604786
UDI/DI 00887761967533
b) REF 1604788
UDI/DI 00887761967526
c) REF 1723633
UDI/DI 00887761967519 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