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Urgent Medical Device Field Correction: Löwenstein Medical Technology

By February 15, 2023Recalls

About the Recall:

Löwenstein Medical Technology has initiated a voluntary field safety notice in connection with a potential hazard due to the influence on the ventilation function of the LUISA (LM150TD) ventilator.

The potential is for a malfunction of the inspiratory trigger of the LUISA ventilators with firmware version 1.5.0030 and may occur in rare cases if the ventilator is used with a single circuit valve system.

As of today, no serious incidents related to this issue have been reported.

Impacted customers will receive written notification of the field correction with instructions to report affected devices and to arrange for the provider to complete the update.