FDA-Device2012-11-28Class II
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
KCI USA, Inc.
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.
Sold states
Nationwide Distribution including AL, CA, CO, OK and GA.
Affected count
282 units
Manufactured in
4958 Stout Dr, N/A, San Antonio, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0409-2013Don't want to check this manually?
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