Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
This recall is currently active, issued August 31, 2018. It was issued by Ge Healthcare, Llc.
- Company
- Ge Healthcare, Llc
- Recall Initiated
- August 31, 2018
- Recall Number
- Z-0519-2019
- Quantity
- Approximately 182,640 monitoring systems for Dash 3000/4000/5000
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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, 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.
Lot / Code Info
All monitors
Root Cause
Software design
Action Taken
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.