Is Compella Bariatric Bed System recalled?

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains. Status: Voluntary: Firm initiated Initial Firm Notification: Letter Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Jamaica, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkmenistan, UAE, and UK.

Medium RiskFDA Device

Baxter Healthcare Corporation: Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

Agency Publication Date: March 23, 2022

Affected Products

Product: Compella Bariatric Bed System

All lots/serial numbers UDI information: Compella Bariatric Bed - 00887761000902

Product: Compella Therapy Air Supply Unit

All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89644

Status: Active

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 2 products (5186 units; 6022 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.