FDA recall Z-0092-2021

Getinge Group Logistics America, LLC · Class II · device

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.

Reason for recall

A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2020-09-17
Report date
2020-10-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0092-2021