FDA recall Z-0820-2022

Product

Compella Bariatric Bed System

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, Turkmenistan, UAE, and UK.

Key facts

Status

Ongoing

Initiation date

2022-02-14

Report date

2022-03-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

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