FDA-Device2015-03-11Class II
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
Arjo Hospital Equipment AB
Hazard
The recalled devices labeling and instructions for use contain unapproved medical claims.
Sold states
Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
Affected count
567 units
Manufactured in
HANS MICHELSENSGATAN 10, N/A, Malm¿, N/A, Sweden
Products
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1218-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief