FDA-Device2015-03-11Class II
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention 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
226 units
Manufactured in
HANS MICHELSENSGATAN 10, N/A, Malm¿, N/A, Sweden
Products
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1217-2015Don't want to check this manually?
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