FDA · Medical device recall

Dash 3000 Patient Monitoring System is used to monitor physiologic… and 5 more products

Dec. 5, 2018 Class II

Date: Dec. 5, 2018
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: GE Healthcare, LLC
Reason: 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 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.

6 products in this recall

Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult…

Product: Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Quantity: Approximately 182,640 monitoring systems for Dash 3000/4000/5000
Codes and lots: All monitors
Recall started: Aug. 31, 2018
Device type: Stimulator, Vestibular Acceleration, Therapeutic
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0519-2019

Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult…

Product: Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Quantity: Approximately 182,640 monitoring systems for Dash 3000/4000/5000
Codes and lots: All monitors
Recall started: Aug. 31, 2018
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0520-2019

Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult…

Product: Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Quantity: Approximately 182,640 monitoring systems for Dash 3000/4000/5000
Codes and lots: All monitors
Recall started: Aug. 31, 2018
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0521-2019

Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult…

Product: Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Quantity: Approximately 73,673 Solar 8000i and 8000M monitoring systems
Codes and lots: All monitors
Recall started: Aug. 31, 2018
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0522-2019

Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult…

Product: Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Quantity: Approximately 73,673 Solar 8000i and 8000M monitoring systems
Codes and lots: All monitors
Recall started: Aug. 31, 2018
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0523-2019

Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult…

Product: Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Quantity: Approximately 3,864 monitoring systems
Codes and lots: All monitors
Recall started: Aug. 31, 2018
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0524-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0519-2019, Z-0520-2019, Z-0521-2019, Z-0522-2019, Z-0523-2019, Z-0524-2019. The agency record governs; check it and the company before acting.

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