Recall Z-0519-2019 ยท MHZ Stimulator, Vestibular Acceleration, Therapeutic
GE Healthcare, LLC
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
| Date | Aug 31, 2018 |
| Status | Open, Classified |
| 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. |
| 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 | 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, Bosn |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992929 | DASH 3000 PATIENT MONITOR General Electric Medical Systems Information Techn, Nov 26, 1999 |