ArjoHuntleigh Inc.: Medical Device Recall in 2014 - (Recall #: Z-0926-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 11, 2013

Date Posted: February 12, 2014

Recall Number: Z-0926-2014

Event ID: 67248

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

Status: Terminated

Product Quantity: 231 units

Code Information:

Model #209500

Distribution Pattern:

US Nationwide and Middle East

Voluntary or Mandated:

Voluntary: Firm initiated