# FDA recall Z-0522-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2018-08-31.

## Product

Solar 8000i Patient Monitoring System  is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

## Reason for recall

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

## Distribution

Distribution was made nationwide, including Puerto Rico, Guam, and Samoa.  There was also government and military distribution.    Foreign distribution was made to Canada, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cameroon, Chile, China, Colombia, Costa Rica, Cota D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuadore, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Namibia, Nepal, Netherlands,  New Zealand, Nicaragua, Nigeria, Norway, Oman, 

## Key facts

- **Recall number:** Z-0522-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-08-31
- **Report date:** 2018-12-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0522-2019

## Citation

> AI Analytics. FDA recall Z-0522-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0522-2019. Source: US FDA. Licensed CC0.

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