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.
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 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.
- 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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