Baxter Operating Table TruSystem 7000 recalled for battery electrical hazards
Baxter Healthcare is recalling the TruSystem 7000 (dV) V operating table worldwide due to batteries and connectors that may experience electrical short-circuits and emit smoke.
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: FDA Class II device with electrical hazard risk (battery short-circuits and smoke emission) that could cause fire or burn injury. No illnesses or injuries have been reported to date, consistent with a high-risk product pending incident confirmation.
Plain-English summary
Baxter Healthcare Corporation is recalling the Operating Table TruSystem 7000 (dV) V (Product code REF 1841083) due to reports of electrical hazards in the device's batteries and connectors.
The firm received customer reports that the batteries and their connectors have experienced electrical short-circuits and/or emitted smoke. These electrical faults create a risk of fire and potential burn injury to patients and operating room personnel.
The device is distributed worldwide. Affected units can be identified by Product code REF 1841083, UDI/DI 00887761974227, and all serial numbers. Customers who have received this equipment should contact Baxter Healthcare Corporation for further information and guidance on the recall.
The recalled product
- Product
- Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- electrical-short-circuit
- smoke-emission
- 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 00887761974227
- All Serial Numbers
Distribution
Distribution scope not specified by the agency.
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