Recall Z-0982-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
| Date | Feb 14, 2014 (initiated Nov 27, 2013) |
| Status | Terminated |
| Reason | GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE" CIC Pro Central Station*. 2. Dash displays distorted ECG waveforms in combination monitoring mode. 3. Dash incorrectly becomes Time Master on the Unity Network. 4. |
| Root cause | Software design |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated November 27,2013. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact Technical Support at 1-800-558-7044 or your local Service Representative). |
| Quantity | 178,711 (92,123 US, 86,588 OUS) |
| Distribution | Worldwide Distribution: USA (nationwide) including DC and PR; and Internationally to: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CAMEROON, CANDA, CARIBBEAN, CHILE, CHINA, COLOMBIA, C |
| FDA record | Open on fda.gov |