Tuesday, June 19, 2012

Nidek Medical Products, Inc. issues an Urgent Medical Device Correction affecting oxygen concentrators

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06/19/2012 11:27 AM EDT

Nidek Medical Products, Inc., today announced that the U.S. Food and Drug Administration (FDA) has classified Nidek’s voluntary recall action regarding capacitor-related fires in Medical Mark5 Nuvo Lite Oxygen concentrators as a Class I recall. The affected devices were manufactured and distributed from January 2004 through May 2010 with serial numbers in the range of 042-10000 through 102-09335.

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