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.
Notas adicionales en la data
Defibrillator/monitor - Product Code MJK
White screen lock up: lifepak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. this may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.
On 04/27/2007 firm sent letters via return receipt to all domestic and foreign customers. The letter recommends for customers to turn the defibrillator power off and back on to restore normal operation in the event of a white screen condition. In addition, the letter advises that a representative from the firm will contact customer to make arrangements to provide a software upgrade to correct the issue.