KCI USA, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0409-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction

Product Classification:

Class II

Date Initiated: June 27, 2012

Date Posted: November 28, 2012

Recall Number: Z-0409-2013

Event ID: 62805

Reason for Recall:

The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.

Status: Terminated

Product Quantity: 282 units

Code Information:

Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.

Distribution Pattern:

Nationwide Distribution including AL, CA, CO, OK and GA.

Voluntary or Mandated:

Voluntary: Firm initiated