International safety notice

Fabian HFO, fabian +nCPAP evolution, and fabian Therapy evolution - IFUAddendum2

Ireland / HPRA · IRL · Sep 2, 2021

Key facts

Title Fabian HFO, fabian +nCPAP evolution, and fabian Therapy evolution - IFUAddendum2
Regulator Ireland / HPRA
Country IRL
Brand Fabian HFO, fabian +nCPAP evolution, and fabian Therapy evolution - IFUAddendum2
Manufacturer Fabian HFO, fabian +nCPAP evolution, and fabian Therapy evolution - IFUAddendum2
Models ETCO2, 5.1.4.2, 53MBAR, 7.3.3, CMH2O, 0.5CMH20, TCCO2, FSCA-21-002, PRE-4TH, V5.2.2, 5.1.4.1, FSCA-21-003 and 2 more
Event type Safety Notice
Date Sep 2, 2021
Regulator page hpra.ie

At a glance

  • No Recall
  • Yes Field safety notice

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