Draeger Oxylog 3000 Plus Ventilators Recalled Due to Potentiometer Fault
Draeger Medical Systems is recalling three Oxylog 3000 plus ventilators because the control knobs may interrupt contact, causing the device to stop ventilation.
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 the rubric mandates a minimum score of 4 (Severe) due to the potential for serious adverse health consequences from the cessation of ventilation.
Plain-English summary
Draeger Medical Systems, Inc. is recalling three units of the Oxylog 3000 plus emergency and transport ventilator (Part number: 5704833). The affected units have serial numbers ASEK-0003, ASEK-0004, and ASEK-0005. These devices were distributed nationwide in the United States, specifically in the states of Wisconsin and New York.
The recall is due to a defect in the potentiometers (knobs) used to set ventilation parameters. These components may experience interrupted contact, which causes the device to discontinue ventilation. When this occurs, the ventilator triggers an audible alarm and displays the error message "Poti unplugged."
Healthcare facilities and users who possess these specific serial numbers should contact Draeger Medical Systems, Inc. for instructions on how to resolve the issue. The recall is classified as Class I by the FDA.
The recalled product
- Product
- Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
- Manufacturer
- Draeger Medical Systems, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Oxylog 3000 plus
- Part number: 5704833 with serial numbers: ASEK-0003
- ASEK-0004
- ASEK-0005
Distribution
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