Recall Z-0359-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
Power supply boards on Dash 3000, 4000 and 5000 Monitors. GE Healthcare, 8200 West Tower Avenue, Milwaukee, WI 53223.
| Date | Nov 15, 2010 (initiated Oct 11, 2010) |
| Status | Terminated |
| Reason | The power supply board in GE Healthcare Dash 3000, 4000 and 5000 patient monitors may fail due to insufficient solder of a component. Insufficient solder on the power supply board could result in excess EMC emissions, smoking of components and eventual failure of the power supply, tripping of the fuse and immediate shutdown resulting in a loss of monitoring that could delay recognition of a clinic |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare issued an "Urgent Medical Device Correction" letter dated October 8, 2010, which described the loss of monitoring issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Customers were instructed to remove the units from use. Local service representatives will contact firms to schedule installation of replacement power supply boards. GE Healthcare can be contacted at 1-800-558-7044, Option 2, Technical Support, about this correction. |
| Quantity | 137 |
| Distribution | Worldwide Distribution: USA in the states of IL, NV, TX, and VA, and the countries of Australia, Brazil, China, Japan, South Korea, and Taiwan. |
| 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 |