Baxter Operating Table TruSystem 7000 V Recalled for Battery Short-Circuit Risk
Baxter Healthcare is recalling the TruSystem 7000 V operating table due to reports of battery and connector short-circuits and smoke emissions. Four units with worldwide distribution are affected.
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 an FDA Class II recall of a surgical device with confirmed electrical short-circuit and smoke emission hazards reported by customers. No injuries or illnesses have been reported, but the potential for serious harm in the operating room environment justifies a High severity rating per the rubric's criterion for risk-of-harm products without reported injury.
Plain-English summary
The Baxter Operating Table TruSystem 7000 V (Product code REF 1841050) is being recalled worldwide by Baxter Healthcare Corporation. The recall affects four units with all serial numbers included.
Baxter Healthcare Corporation received customer reports that the device's batteries and electrical connectors experienced short-circuits and emitted smoke. The FDA issued a Class II recall for this medical device due to the identified electrical hazards.
The recalled product
- Product
- Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 4
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 00887761974241
- 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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