Power supply boards on Dash 3000, 4000 and 5000 Monitors. GE Healthcare, 8200 West Tower Avenue, Milwaukee, WI 53223.
FDA Recall Z-0359-2011 · Posted 2010-11-15
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2010-10-11
Date Terminated2012-05-29
Product Quantity137
Reason for Recall
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
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: USA in the states of IL, NV, TX, and VA, and the countries of Australia, Brazil, China, Japan, South Korea, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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