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FDA (Device enforcement)Recalled 2022-02-14closedclass ii

Baxter Healthcare Corporation: Compella Bariatric Bed System

Is my product affected?

Compella Bariatric Bed System

  • UPC 00887761000902

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling the Compella Bariatric Bed System due to a potential hazard with the power cord. The power cord may become damaged in a way that exposes the power conductors, creating a risk of electric shock from the power mains. Approximately 5,186 units have been distributed worldwide, including throughout the United States and in countries such as Canada, Australia, Mexico, and many others.

The recall affects all lots and serial numbers of the Compella Bariatric Bed System (UDI: 00887761000902). The recall notice does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains. 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, Turkmenista Quantity: 5186 units Lot/code info: All lots/serial numbers UDI information: Compella Bariatric Bed - 00887761000902

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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