International safety notice

Sislemas Volcano s5i, CORE y CORE Mobile con la verion 2.5 de software FFR/iFR. Ver referencias afectadas en la nota de aviso de la empresa.

Spain / AEMPS · ESP · Jan 15, 2019

Key facts

Title Sislemas Volcano s5i, CORE y CORE Mobile con la verion 2.5 de software FFR/iFR. Ver referencias afectadas en la nota de aviso de la empresa.
Regulator Spain / AEMPS
Country ESP
Brand Sislemas Volcano s5i, CORE y CORE Mobile con la verion 2.5 de software FFR/iFR. Ver referencias afectadas en la nota de aviso de la empresa.
Manufacturer Volcano Corporation, EEUU
Models 91.822.52.89, 400-0100.08, 400-0100.08-R, 28050, 49521, 2019-023, SOFTWARE2.5, 95670, 807400001, 400-0100.07-R, 400-0100.01, 400-0100.07 and 4 more
Event type Safety Notice
Date Jan 15, 2019

At a glance

  • No Recall
  • Yes Field safety notice
  • 1–9 Matching device models in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices