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
Exerciser, powered - Product Code BXB
원인
Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation.
조치
Hocoma issued a letter dated May 27, 2009 to Lokomat users informing them of the affected device. Instructions were provided to avoid further problems with the product and users were asked to complete and return the provided Declaration to Field Safety Notice.
For further information, contact Hocoma at info@hocoma.com.