U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
KCI sent an Urgent - Voluntary Medical Device Correction letter dated June 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that KCI would contact them soon to coorinate a shipment of a replacement of the affected product. For any questions customers were instructed to call 1-800-275-4524, Selection Option 3 followed by Option 2.
For questions regarding this recall call 1-800-275-4524.
Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.
Nationwide Distribution including AL, CA, CO, OK and GA.
제품 설명
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