FDA-Device2015-03-11Class II
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
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
271 units
Manufactured in
HANS MICHELSENSGATAN 10, N/A, Malm¿, N/A, Sweden
Products
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2015Don't want to check this manually?
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