Events

Recall Or Safety Alert for S-ICD systems: SQ-RXTM model 1010, EMBLEMTM model A209 and EMBLEMTM MRI model A219.

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety Alert
  • Date
    2017-07-06
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Event Source URL
    N/A
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Spain.
  • Extra notes in the data
  • Action
    Safety warnings: - Possibility that the S-ICD systems repeatedly supply an atypical amount of energy (similar to the function of induction of arrhythmias) because a specific location of the memory can be corrupted by environmental radiation. - Recommendations for monitoring patients implanted with S-ICD systems.

Device

S-ICD systems: SQ-RXTM model 1010, EMBLEMTM model A209 and EMBLEMTM MRI model A219.
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    AEMPSVFOI