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Getinge Group Logistics America, LLC recalls Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventila
Recalled October 21, 2020 · FDA recall Z-0092-2021 · Getinge Group Logistics America
Hazard
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully. · FDA Class II
Units
431 units
Sold at
Domestic distribution to AZ CA GA IL MN MO NC NJ NY RI SC TX VA WI WV Foreign distributed to Bosnia and Herzegovina, Czech Republic, France, Germany, India, Indonesia, Iraq, Italy, Kenya, Republic of Korea, Lebanon, Libyan Arab Jamahiriya, Norway, Palestine, Peru, Qatar, Saudi Arabia,Slovakia, Sri Lanka, Sweden Thailand, Turkmenistan, Ukraine and United Arab Emirates.
Description
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
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 Neonates, Pediatric and Adults.
Manufacturer(s)
Getinge Group Logistics America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →