Baxter Operating Table TruSystem 7000 Recalled for Battery Short-Circuit Risk
Baxter Healthcare Corporation is recalling the TruSystem 7000 Operating Table due to battery and connector short-circuits that can emit smoke, creating fire and electrical hazards during surgery.
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 a Class II recall involving a medical operating table where the battery system can short-circuit and emit smoke, creating fire and electrical hazards in the operating room. No injuries or deaths have been reported, placing this in the High (3) category as a risk-of-harm product without reported injury.
Plain-English summary
Baxter Healthcare Corporation is recalling the Operating Table TruSystem 7000 (Product code REF 1841046) due to a hazard with the battery system. Approximately 397 units of this equipment have been distributed worldwide.
The batteries and their connectors have been reported to experience electrical short-circuits and emit smoke. These failures create fire and electrical hazards that could endanger patients and operating room personnel during surgical procedures.
Healthcare facilities using this operating table should immediately discontinue use and contact Baxter Healthcare Corporation for repair, replacement, or other resolution options. All serial numbers of the affected product are included in this recall.
The recalled product
- Product
- Baxter Operating Table TruSystem 7000, Product code REF 1841046
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 397
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 00887761968714
- 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.
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