FDA Issues Class I Recall for Dräger’s Emergency Transport Ventilators

Dräger Medical Inc. is recalling certain Dräger Oxylog Emergency Transport Ventilators because a system error can lead to a halt in ventilation therapy. The Food and Drug Administration (FDA) has identified this as Class I, the most serious type of recall, because use of these devices may cause serious injuries or even death.

The recalled devices are used in hospitals or during patient transport to provide constant breathing support for adults and children. An electrical issue can cause the ventilators to stop working if the control knobs are not regularly used. If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. The recall includes 117 units of the following models: Dräger Oxylog 2000 plus, Oxylog 3000, and Oxylog 3000 Plus Ventilators. See the FDA notice for additional details on how to identify the recalled devices. Dräger sent a letter to all customers with affected devices with instructions for repairing the devices by releasing the electrical contact resistance in the control knobs.

Source: FDA