Recall archive
30 recalls · page 2 of 2
Reported Aug 26, 2015
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand — The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
FDA (openFDA device enforcement)
Reported Aug 5, 2015
Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand — the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its…
FDA (openFDA device enforcement)
Reported Apr 16, 2014
Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand · Product details · Reason for recall — Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became…
FDA (openFDA device enforcement)
Reported Nov 20, 2013
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand · Product · Product details · Reason for recall — Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell…
FDA (openFDA device enforcement)
Reported Oct 16, 2013
Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Draeger Medical, Inc.
Matched: Brand · Product · Product details · Reason for recall — During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test…
FDA (openFDA device enforcement)
Reported Mar 20, 2013
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
Matched: Brand · Product · Product details — The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable…
FDA (openFDA device enforcement)
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