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.
What this means for you
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
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.
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