FDAFDA · Food and drugs·Recall number Z-0926-2014
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.
Published February 12, 2014 · Recall initiated: September 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- ArjoHuntleigh Inc.
- Distributor
- US Nationwide and Middle East
- Lot
- Model #209500
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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