# FDA recall Z-1560-2022

> **Getinge Usa Sales Inc** · Class I · device recall initiated 2022-07-20.

## Product

Maquet Critical Care AB/Getinge   Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000

## Reason for recall

Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and consequently desaturation, with patient outcomes including hypoxemia and hypoxic injury, which might result in circulatory failure.

## Distribution

Worldwide distribution. US nationwide, Poland, Spain, France, Germany, Czech Republic, Italy, Belgium, Estonia, Greece, Finland, Portugal, Netherlands, Romania, Austria, Slovakia, Lithuania, Ireland, Latvia, Norway, Sweden, Malaysia, China, Singapore, Taiwan, Iceland, Slovenia, Hungary, Bulgaria, Denmark, Croatia, United Kingdom, Russia, Hong Kong, United Arab Emirates, Canada, Switzerland, Australia, New Zealand, Serbia, Kenya, South Africa, Palestine, India, Colombia, Macau, Argentina, Mexico, Japan, Brazil, Israel, South Korea, Turkey, Peru, Ukraine, Thailand, Polynesia(French), Morocco, Saudi Arabia, Iran, Martinique (French), Costa Rica, Kuwait, Algeria, Saint Helena, Syria, Chile, Qatar, Fiji, Lebanon, Sri Lanka, Jordan, Oman, Pakistan, Ecuador, Botswana, Mozambique, Netherlands, Antilles, Bolivia, Andorra, Aruba, Faroe Islands, Egypt, Libya, Indonesia, Bahrain, Uruguay, Guadeloupe (French), Puerto Rico, Bosnia-Herzegovina, Paraguay, Nepal, Nicaragua, Vietnam, Tunisia, El Salvado

## Key facts

- **Recall number:** Z-1560-2022
- **Recalling firm:** Getinge Usa Sales Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-20
- **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-1560-2022

## Citation

> AI Analytics. FDA recall Z-1560-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1560-2022. Source: US FDA. Licensed CC0.

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