CLASS II ONGOING Device recall · Reported 5 Dec 2018 · FDA Enforcement Report

Solar 8000M Patient Monitoring System is used to monitor recalled

GE Healthcare is recalling Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on, distributed nationwide in the US. The recall was initiated on 31 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll monitors

Quantity recalledApproximately 73,673 Solar 8000i and 8000M monitoring systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0523-2019
FDA event ID: 81058
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 31 Aug 2018
FDA classified: 29 Nov 2018
Reported: 5 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

31 Aug 2018	Recall initiated by company
29 Nov 2018	Classified by FDA	+90 days
5 Dec 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

All monitors

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 81058

This product is part of a recall event; the main page for the event is Dash 5000 Patient Monitoring System is used to monitor recalled.

Reported	Class	Recall	Company	Reason	Where
5 Dec 2018	CLASS II	Dash 5000 Patient Monitoring System is used to monitor recalled	GE Healthcare	Other	Nationwide
5 Dec 2018	CLASS II	Solar 9500 Information Monitoring System is used to monitor recalled	GE Healthcare	Other	Nationwide
5 Dec 2018	CLASS II	Dash 3000 Patient Monitoring System is used to monitor recalled	GE Healthcare	Other	Nationwide
5 Dec 2018	CLASS II	Dash 4000 Patient Monitoring System is used to monitor recalled	GE Healthcare	Other	Nationwide
5 Dec 2018	CLASS II	Solar 8000i Patient Monitoring System is used to monitor recalled	GE Healthcare	Other	Nationwide

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