International safety notice

fabian HFO Classic and HFOi Ventilator

Ireland / HPRA · IRL · May 2, 2024

Key facts

Title fabian HFO Classic and HFOi Ventilator
Regulator Ireland / HPRA
Country IRL
Brand fabian HFO Classic and HFOi Ventilator
Manufacturer Acutronic Medical Systems AG
Models 2024-05, FSCA-24-003-FSN-1, 17640140860043, V5.2.1, ETCO2, FSCA-21-003, 112001113001, 2024-04-15, 17640140860203, 5.2.2, 122001, 112001 and 7 more
Event type Safety Notice
Date May 2, 2024
Regulator page hpra.ie

At a glance

  • No Recall
  • Yes Field safety notice
  • 10–99 Matching device models in FDA data
  • 10–99 Matching catalog numbers 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

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