# FDA recall Z-2266-2018

> **Datex-Ohmeda, Inc.** · Class II · device recall initiated 2017-12-08.

## Product

CARESCAPE R860 ventilators with software version 10SP05    Product Usage:  The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules. Not all features are available for all patient types or product configurations. The CARESCAPE R860 ventilator is not a pulmonary function calculation device. The system is designed for facility use, including within facility transport, and should only be used under the orders of a clinician.

## Reason for recall

Potential for the display processor to experience an  unexpected failure.

## Distribution

Worldwide Distribution -  USA (nationwide) Distribution to the states of : AL, AZ, CA, GA, ID, IL, IN, MS, NC, NJ, NK, NV, OH, OK, RI, TX, and WI., and to the countries of :  Albania, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia,  Cyprus, Czech Republic, Ecuador, El Salvador, Estonia, Ethiopia,  Egypt, Finland, France, Germany,  Ghana, Hungary, India, Indonesia, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia,  Mexico, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Pakistan,  Palestine, Peru, Philippines, Poland, Russia, Saudi Arabia, Senegal, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,  United Kingdom, Uruguay, and Vietnam

## Key facts

- **Recall number:** Z-2266-2018
- **Recalling firm:** Datex-Ohmeda, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-08
- **Report date:** 2018-06-27
- **Termination date:** 2021-04-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Madison, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2266-2018

## Citation

> AI Analytics. FDA recall Z-2266-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2266-2018. Source: US FDA. Licensed CC0.

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