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Arjo Hospital Equipment AB recalls Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and preve
Recalled March 11, 2015 · FDA recall Z-1217-2015 · Arjo Hospital Equipment AB
Hazard
The recalled devices labeling and instructions for use contain unapproved medical claims. · FDA Class II
Units
226 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
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention 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 →