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Arjo Hospital Equipment AB recalls RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for
Recalled March 11, 2015 · FDA recall Z-1216-2015 · Arjo Hospital Equipment AB
Hazard
The recalled devices labeling and instructions for use contain unapproved medical claims. · FDA Class II
Units
271 units
Sold at
Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
Description
The recalled devices labeling and instructions for use contain unapproved medical claims.
Product
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
Manufacturer(s)
Arjo Hospital Equipment AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →