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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
데이터 추가 비고
unknown device name - Product Code I--TI
원인
Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt.
조치
Permobil Inc has notified its field representatives of the voluntary recall and these representatives have been provided with lists of each Chairman 2K serial number and the Dealer to which the wheelchair was sold.