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Open, Classified

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

FDA Recall Z-0523-2019 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2018-08-31
Product QuantityApproximately 73,673 Solar 8000i and 8000M monitoring systems

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.

Firm Action

The recalling firm issued letters dated 8/31/2018 via FedEx on 8/31/2018 informing the customer of the issue and providing safety instructions for mitigation of the issue if a prolonged network overload occurs and the Dash and/or Solar patient monitor on the network does not resume normal functionality in approximately 90 seconds.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012467SOLAR 8000M SYSTEMGeneral Electric Medical Systems Information Techn · 2002-02-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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