Compella Bariatric Bed System Recall—Power Cord Electrical Shock Risk
Baxter Healthcare is recalling the Compella Bariatric Bed System due to potential power cord damage that could expose electrical conductors, creating a shock hazard. Approximately 5186 units worldwide 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 medical device with potential electrical shock hazard from power cord damage. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Baxter Healthcare Corporation is recalling the Compella Bariatric Bed System due to potential power cord damage. The power cord may become damaged in a way that exposes electrical conductors, creating a risk of electrical shock from the power supply.
The recalled beds were distributed worldwide, including throughout the United States and to 35 additional countries. Approximately 5186 units have been identified in this recall. The affected product is identified by UDI 00887761000902.
The recalled product
- Product
- Compella Bariatric Bed System
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Hospital Bed
- Affected units
- 5,186
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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