Arjo Hospital Equipment AB recalls Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevent…
- Recall date
- December 3, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1217-2015
- FDA classification
- Class II
- Brand / firm
- Arjo Hospital Equipment AB
- Sold / distributed
- Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
Why it was recalled
The recalled devices labeling and instructions for use contain unapproved medical claims.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
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