# FDA recall Z-1568-2022

> **Getinge Usa Sales Inc** · Class II · device recall initiated 2022-07-21.

## Product

Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients.  Model Number: 	6882000 (equipped with 6881999 mobile cart)

## Reason for recall

Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel (IL), Japan (JP), Mexico (MX), Pakistan (PK), Saudi Arabia (SA), South Africa (ZA), South Korea (KR), Switzerland (CH), Taiwan (TW), Turkey (TR), and United Arab Emirates (AE).

## Key facts

- **Recall number:** Z-1568-2022
- **Recalling firm:** Getinge Usa Sales Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-21
- **Report date:** 2022-08-31

- **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-1568-2022

## Citation

> AI Analytics. FDA recall Z-1568-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1568-2022. Source: US FDA. Licensed CC0.

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