International safety notice

Urgent Field Safety Notice for BIB/Orbera365 Intragastric Balloon Systems by apollo endosurgery

Germany / BfArM · DEU · Jul 22, 2019

Key facts

Title Urgent Field Safety Notice for BIB/Orbera365 Intragastric Balloon Systems by apollo endosurgery
Regulator Germany / BfArM
Country DEU
Brand BIB/Orbera365 Intragastric Balloon Systems
Manufacturer apollo endosurgery
Models B-40800, FSCA-19-001, 512.279.5100, GRF-00200-00R05, B-50012, 78746, 1-512-279-5100, GRF-00377-00R08, FSN-19-001, ORBERA365, 512.279.5105
Date Jul 22, 2019
Regulator page bfarm.de

At a glance

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