GE Healthcare…

Date

Feb. 20, 2013

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

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.

Reason

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.

Distribution pattern

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.

Quantity

10,497

Codes and lots

Mfg Lot or Serial # SE507460028GA SE507460050GA SE507460053GA SE507460054GA SE507460055GA SE507460056GA SE507460057GA SE507460058GA SE507460059GA SE507460060GA SE507460061GA SE507460062GA SE507460063GA SE507460066GA SE507460067GA SE507480070GA SE507480071GA SE507480073GA SE507480075GA SE507480077GA SE507480078GA SE507480079GA SE507480080GA SE507480082GA SE507480083GA SE507480084GA SE507480085GA SE507480091GA SE507480098GA SE507480099GA SE507480101GA SE507480102GA SE507480105GA SE507480108GA SE507480109GA SE507480110GA SE507480115GA SE507480118GA SE507480120GA SE507480123GA SE507480124GA SE507480125GA SE507480135GA SE507480139GA SE507480148GA SE507480163GA SE507480168GA SE507480178GA SE507480185GA SE507480191GA SE507480192GA SE507480196GA SE507480197GA SE507480198GA SE507480201GA SE507480213GA SE507480217GA SE507480222GA SE507480225GA SE507480226GA SE507480230GA SE507480233GA SE507480234GA SE507480237GA SE507480245GA SE507480246GA SE507480247GA SE507480248GA SE507480250GA SE507480251GA 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Recall started

June 13, 2012

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

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.

Recall number

Z-0814-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0814-2013. The agency record governs; check it and the company before acting.