International safety notice

fabian HFO, fabian +nCPAP evolution, fabian Therapy evolution

Spain / AEMPS · ESP · Sep 17, 2021

Key facts

Title fabian HFO, fabian +nCPAP evolution, fabian Therapy evolution
Regulator Spain / AEMPS
Country ESP
Brand fabian HFO, fabian +nCPAP evolution, fabian Therapy evolution
Manufacturer Acutronic Medical Systems AG, Suiza.
Models 91.822.52.89, FSCA-21-002_FSCA-21-003-FSN-1, 122012, 5.2.2, V5.2.1, 111001, 5.1.4.2, 111001111001.01, CMH2O, V5.2.2, 122001122012, 121001 and 19 more
Event type Safety Notice
Date Sep 17, 2021

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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