International safety notice

Urgent Field Safety Notice for SanaBike 500/ERG 910 plus, SanaBike 1000/ERG 911 plus, SanaComfort 1000/ERG 911 Comfort, SanaCouch 1000/ ERG 911L, SanaCardio 1000/ERG 911LS by Ganshorn Medizin Electronic GmbH

Germany / BfArM · DEU · Aug 19, 2024

Key facts

Title Urgent Field Safety Notice for SanaBike 500/ERG 910 plus, SanaBike 1000/ERG 911 plus, SanaComfort 1000/ERG 911 Comfort, SanaCouch 1000/ ERG 911L, SanaCardio 1000/ERG 911LS by Ganshorn Medizin Electronic GmbH
Regulator Germany / BfArM
Country DEU
Brand SanaBike 500/ERG 910 plus, SanaBike 1000/ERG 911 plus, SanaComfort 1000/ERG 911 Comfort, SanaCouch 1000/ ERG 911L, SanaCardio 1000/ERG 911LS
Manufacturer Ganshorn Medizin Electronic GmbH
Models 30002202, 30300346, 11-30-500, 30300328, 30002116, GMEQI-62, 50065, 12-30-101, 50073, 27.02.2023, 30102667, 30102597 and 97 more
Date Aug 19, 2024
Regulator page bfarm.de

At a glance

  • No Recall
  • No 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

Browse all International device safety notices