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
Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
원인
Braemar inc., became aware of a battery related incident that occurred with an able battery pack being used in a braemar er920w wireless event monitor. the event did not result in any patient related injury or present any clinical impact.
조치
Braemar began notifying customers by telephone on 5/2/2011. Braemar issued Advisory Notice letter P/N 600-0662-00 RevA dated May 16, 2011. The letter was sent by UPS to all consignees.The letter described the problem and the product involved in the recall. Consignees were advised not to use the battery pack in the Braemar ER920W or Braemar Fusion device and requested consignees to complete and return the Verification Form.
For questions regarding this recall call 651-286-8620.