Recall Z-0813-2013 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
| Date | Feb 13, 2013 (initiated Jun 13, 2012) |
| Status | Terminated |
| Reason | GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient m |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare sent an Important Product Information letter dated June 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told the otherboard would be replaced, on request, should the customer continue to expeience the issue with the affected product. A second letter dated August 30, 2012, was sent on September 5, 2012, informing consignees that the motherboard replacement did not fully correct the issues. Therefore, the motherboard replacement field action had been suspended. It further explaine |
| Quantity | 119,262 |
| Distribution | Nationwide Distribution - ALL STATES IN CONTINENTAL USA INCLUDING PR and DC excluding AK, DE, ND, and VT. ALGERIA, AUSTRALIA, ANGOLA, ARGENTINA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CRO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073462 | MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES Ge Medical Systems Information Technologies, Jan 11, 2008 |