The Recall Desk
SevereFDA (Devices)·Z-0692-2016·Announced 2016-02-10

Draeger Oxylog 3000 Ventilators Recalled for Software Error

Draeger Medical is recalling Oxylog 3000 and Oxylog 3000 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 FDA classified this recall as Class I, which mandates a severity score of at least 4 according to the rubric.

Plain-English summary

Draeger Medical, Inc. is recalling 402 units of Oxylog 3000 and Oxylog 3000 Plus emergency transport ventilators. The affected units were distributed nationwide between April 2007 and December 2015.

The recall is due to a software issue where the error message "Poti unplugged" may be generated incorrectly. When this error occurs, the device generates 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.

The recalled product

Product
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.

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 →