Z-0926-2014 Class II Terminated

Recalled by ArjoHuntleigh Inc. — San Antonio, TX

Recall Details

Product Type
Devices
Report Date
February 12, 2014
Initiation Date
September 11, 2013
Termination Date
January 8, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
231 units

Product Description

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.

Reason for Recall

The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient

Distribution Pattern

US Nationwide and Middle East

Code Information

Model #209500