Recall Z-0092-2021— Getinge Group Logistics America, LLC

Name: FDA recall Z-0092-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-17

Class II · Ongoing

Class II FDA medical device recall by Getinge Group Logistics America, LLC, initiated 2020-09-17. It names one FDA 510(k) clearance: K123149. 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: A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully..

Recalling firm: Getinge Group Logistics America, LLC
Classification: Class II
Status: Ongoing
Initiated: 2020-09-17
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K123149 — SERVO-I VENTILATOR SYSTEMMaquet Critical Care AB·cleared 2014-06-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.