Z-0519-2019Class II

Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and...

Name: Z-0519-2019 Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and...
Creator: GE Healthcare, LLC
Published: 2018-08-31
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-08-31 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients on 2018-08-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0519-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-08-31
Posted: 2018-11-29
Recalling firm: GE Healthcare
Product: Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Product code: MHZ Stimulator, Vestibular Acceleration, Therapeutic
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: Approximately 182,640 monitoring systems for Dash 3000/4000/5000
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.
Product codes and lots: All monitors

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0519-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0519-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-05	2018-11-29
Z-0520-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-05	2018-11-29
Z-0521-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-05	2018-11-29
Z-0522-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-05	2018-11-29
Z-0523-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-05	2018-11-29
Z-0524-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-05	2018-11-29

Product code MHZ

K992929Class IIDash 3000 Patient MonitorGeneral Electric Medical Systems Information Techn / cleared 1999-11-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)