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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
데이터 추가 비고
원인
Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
조치
Zoll Medical issued Urgent Device Correction notices dated 12/30/11 via UPS/Registered Mail. The letter described the issue and identified the affected product. ZOLL recommended that customers alert their staff of the issue, that the electrodes should be kept away from a fluid environment, to use caution in handling the electrodes if they are subjected to a fluid environment and maintain safe defibrillation practice, and seek a replacement if available. Also customers should contact Zoll 1-800-348-9011 for product replacement. The firm plans to replace the affected lots free of charge.
Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) || Part number: 8900-0401 || Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients.