Getinge clarifies FDA communication to health care providers
Following the media coverage relating to the FDA communication to health care providers Getinge would like to make the following clarification.On November 1, 2018, the American Food and Drug Administration (FDA) posted a Health Care Provider letter on the FDA Website regarding post market safety concerns with Maquet/Getinge ballonpump products. Getinge would like to clarify that FDA is evaluating recent medical device reports (MDR) of ballonpumps shutting down while running on battery power. The communication from FDA today is part of a normal process to inform health care facilities and