Z-0926-2014 Class II Terminated
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