FDA-Device2013-02-13Class II
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
Oxus America, Inc.
Hazard
Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.
Sold states
Worldwide Distribution-USA including the states of New York, Michigan, Colorado, Texas, Iowa, Florida, Georgia, Ohio, Wisconsin, Oregon, Alabama, Illinois, Utah, Oklahoma, West Virginia and California and the countries of Canada, European Union, South Africa, Korea and Brazil.
Affected count
1724 total units
Manufactured in
1685 Northfield Dr, N/A, Rochester Hills, MI, United States
Products
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0768-2013Don't want to check this manually?
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