Baxter TruSystem 7000 Operating Tables Recalled for Electrical Short-Circuits
Baxter Healthcare is recalling 13 TruSystem 7000 operating tables because their batteries and connectors experienced electrical short-circuits and emitted 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with a defect (electrical short-circuit and smoke emission) that poses a significant risk of injury or property damage, fitting the criteria for a Severe rating.
Plain-English summary
Baxter Healthcare Corporation is recalling 13 units of the Baxter Operating Table TruSystem 7000 U14 (MBW) V, product code REF 2065386. The recall was initiated after the firm received customer reports indicating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
The affected units have UDI/DI 00887761973794 and include all serial numbers. The products were distributed worldwide.
The source text does not specify specific instructions for consumers or healthcare facilities regarding the immediate handling of these devices, nor does it report any specific injuries or illnesses resulting from the defect.
The recalled product
- Product
- Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Operating Table
- Affected units
- 13
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 00887761973794
- 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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