# FDA recall Z-0092-2021

> **Getinge Group Logistics America, LLC** · Class II · device recall initiated 2020-09-17.

## 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

- **Recall number:** Z-0092-2021
- **Recalling firm:** Getinge Group Logistics America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-17
- **Report date:** 2020-10-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0092-2021. Retrieved 2026-09-23 from https://api.ai-analytics.org/recall/Z-0092-2021. Source: US FDA. Licensed CC0.

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