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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- Draeger Medical, Inc.
- Category
- Medical Device — Ventilator
Distribution
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.
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