Getinge Servo-i Ventilator Recall for Short Nebulizer Connector
Getinge is recalling 431 Servo-i Ventilators because a nebulizer connector may be shorter than specified, potentially preventing the Aeroneb Nebulizer module from installing successfully.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical fit issue that may prevent the installation of a specific module, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Getinge Group Logistics America, LLC is recalling 431 units of the Servo-i Ventilator (Part No. 6487800, UDI Code 07325710000823). The recall is due to a potentially shorter-than-specified nebulizer connector, which may result in difficulty installing the Aeroneb Nebulizer module to the Servo-i device successfully.
The affected units were distributed domestically to Arizona, California, Georgia, Illinois, Minnesota, Missouri, North Carolina, New Jersey, New York, Rhode Island, South Carolina, Texas, Virginia, Wisconsin, and West Virginia. They were also distributed to foreign locations including Bosnia and Herzegovina, the Czech Republic, France, Germany, India, Indonesia, Iraq, Italy, Kenya, the Republic of Korea, Lebanon, the Libyan Arab Jamahiriya, Norway, Palestine, Peru, Qatar, Saudi Arabia, Slovakia, Sri Lanka, Sweden, Thailand, Turkmenistan, Ukraine, and the United Arab Emirates.
The Servo-i Ventilator is intended for general and critical ventilator care, including low to high end intensive care for neonates, pediatric, and adult patients. The recall is classified as FDA Class II. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for N
- Manufacturer
- Getinge Group Logistics America, LLC
- Category
- Medical Device — Ventilator
- Hazard
- Affected units
- 431
Distribution
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