Recall Z-0926-2014— ArjoHuntleigh Inc.

Class II FDA medical device recall by ArjoHuntleigh Inc., initiated 2013-09-11, terminated 2015-01-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient.

Recalling firm

ArjoHuntleigh Inc.

Classification

Class II

Status

Terminated

Initiated

2013-09-11

Terminated

2015-01-08

Firm location

San Antonio, TX, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.