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.
데이터 추가 비고
Bed, patient rotation, powered - Product Code IKZ
원인
Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
조치
Firm sent a letter with the "Warning: Improper Insertion of the RotoProne Therapy System Buckle Can Lead To Unintentional Bed Exit" to all consignees on 2/23/2011. The letter identified the affected product and the reason for the recall. Customers were instructed to read the attached product warning regarding the proper method to attach the RotoProne buckles and to post it with the device to ensure continued proper use of the buckles. If customers had questions regarding the proper use of the buckles, they were to contact KCI Customer Technical Service at 1-800-275-4524.
KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. || Indicated for treatment and prevention of pulmonary complications.