Device product
Compella Therapy Air Supply Unit
Z-0821-2022
Product summary
- Event
- Event 89644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6022 units
- Official record key
device-enforcement:Z-0821-2022
Official wording
Reason: Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
Code information: All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.