FDA-Device2014-02-12Class II
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Pl
ArjoHuntleigh Inc.
Hazard
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Sold states
US Nationwide and Middle East
Affected count
231 units
Manufactured in
4958 Stout Dr, San Antonio, TX, United States
Products
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0926-2014Don't want to check this manually?
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