Notificaciones De Seguridad De Campo acerca de Innova 2100IQ, Innova 2121IQ, Innova 3100, Innova 3100IQ, Innova 3131IQ, Innova 4100, Innova4100IQ, Innova IGS 620, Innova IGS 630 Cardiovascular X-ray imaging systems equipped with CE marked PDB (Power Distribution Box).

Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.

Advice regarding a device modification. 3rd Party Publications