The Recall Desk
SevereFDA (Devices)·Z-0691-2016·Announced 2016-02-10

Draeger Oxylog 2000 Plus Ventilator Recalled for Malfunction

Draeger Medical is recalling Oxylog 2000 Plus ventilators because a software error can stop ventilation and trigger alarms.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric. The hazard involves the cessation of a life-sustaining function (ventilation), which poses a significant risk of serious adverse health consequences.

Plain-English summary

Draeger Medical, Inc. is recalling the Oxylog 2000 Plus Ventilator, a volume-controlled emergency and transport ventilator with pressure support. The recall involves units with catalog number 5705080 that were distributed nationwide between April 2007 and December 2015.

The recall was initiated because the device may generate an error message stating "Poti unplugged." When this error occurs, the ventilator triggers acoustic and visual alarms, the breathing system releases pressure, and the ventilation function stops operating.

Healthcare facilities and users should contact Draeger Medical for instructions on how to address the issue. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

Product
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →