FDA-Device2020-10-21Class II
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.
Getinge Group Logistics America, LLC
Hazard
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
Sold states
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.
Affected count
431 units
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0092-2021Don't want to check this manually?
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