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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcarr Dash Port 2 Docking Station

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 Class 2 Device Recall GE Healthcarr Dash Port 2 Docking Station see related information
Date Posted February 14, 2013
Recall Status1 Open
Recall Number Z-0814-2013
Recall Event ID 63662
510(K)Number K073462 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product GE Healthcare, Dash Port 2 Docking Station.

Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.
Code Information
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops communicating with the Dash, resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDs in the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped.
FDA Determined
Cause 2
Nonconforming Material/Component
Action GE Healthcare sent an Important Product Information Letter dated June 13, 2012 via FedEx to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter indicated that the motherboard would be replaced, on request, should the customer continue to experience the issue. A second letter dated August 30th 2012 was issued informing consignees that the correction that was initially proposed did not fully correct the issues. Therefore, the motherboard replacement field action had been suspended. It further explained that the correction will be provided at no charge when it is available. For questions contact Technical Support at 1-800-558-7044.
Quantity in Commerce 10,497
Distribution Worldwide Distribution and US (nationwide) including DC and the countries of ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, INDIA, ISRAEL, ITA LY, JAPAN, JORDAN, KUWAIT, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH KOREA, SPAIN SWEDEN SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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