Bed, Patient Rotation, Powered

ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatening event.

RotoRest Delta Advanced Therapy System.

The recalled devices labeling and instructions for use contain unapproved medical claims.

Rotoprone Therapy System.

The recalled devices labeling and instructions for use contain unapproved medical claims.

TriaDyne Proventa Critical Care Therapy System.

The recalled devices labeling and instructions for use contain unapproved medical claims.

The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provid

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

KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500.

Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.

RotoProne Therapy System, Model 209500, Device List Number E232632

Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient.

RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX.

To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.

XPRT Therapy Mattress Systems:

Design control/validation deficiencies.

KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900

Battery outgassing of powered hospital beds