FDA-Device2022-03-30Class II

Compella Bariatric Bed System

Baxter Healthcare Corporation
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.

Sold states
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.
Affected count
5186 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Compella Bariatric Bed System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0820-2022

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