FDA recall on account of premature battery discharge

Category: recall management Industry: healthcare, cosmetics Author: Year:

An on-line commentary by Miriam Schuh for DeviceMed

In the autumn of 2017, following a request from the FDA, Abbott Laboratories had to carry out a recall of their implantable defibrillators. One of the reasons for the order of this corrective measure was the fact that Abbott did not regard the premature discharge of batteries as safety-relevant. 

An overview:

  • safety requirements and liability risks relating to battery-operated medical devices
  • increased probability of a defect is enough to lead to manufacturer's liability in the case of high-risk products 
  • suppliers should be placed under obligation to obtain correct and proper certification 

[March, 13th, 2018]