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KCI USA, Inc. recalls RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of
Recalled November 28, 2012 · FDA recall Z-0409-2013 · KCI USA
Hazard
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. · FDA Class II
Units
282 units
Sold at
Nationwide Distribution including AL, CA, CO, OK and GA.
Description
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.
Product
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
Manufacturer(s)
KCI USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →