Z-0523-2019 Class II Ongoing
FDA device recall Z-0523-2019 was initiated by GE Healthcare, LLC on Aug 31, 2018 and is designated Class II. 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. The recall status is ongoing. Affected quantity: Approximately 73,673 Solar 8000i and 8000M monitoring systems.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 5, 2018
- Initiation Date
- Aug 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Approximately 73,673 Solar 8000i and 8000M monitoring systems
Product Description
Reason for Recall
Distribution Pattern
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, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Republic of Serbia, Reunion, Romania, Russia, Saint Lucia, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen, Yugoslavia, and Zimbabwe.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0523-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026