Nidek Oxygen Concentrator Recall Issued Due to Fire Risk

Federal health regulators are warning that problems with Nidek Medical Products’ Nuvo series of Oxygen Concentrators could lead to serious injury or death. 

The FDA announced on June 21 that it was classifying a Nidek oxygen concentrator recall as a class 1 medical device recall.

The oxygen concentrators, which supply supplemental oxygen to patients at home, have been deemed a fire hazard and have been given the most serious categorization, suggesting that use of the device carries a high probability of someone being severely injured or killed by a fire sparked by one of the devices, or due to the resulting loss of supplemental oxygen

According to Nidek’s recall press release, the Mark 5 Nuvo series of concentrators have a capacitor component which can fail and has caused fires in residential and nursing homes. However, there have been no injuries associated with the fires or failed oxygen concentrators to date.

The recall affects certain models of the Nidek Medical Mark5 Nuvo, Nuvo 8 and Nuvo Lite Oxygen Concentrators. The affected oxygen concentrators were manufactured between January 1, 2004 and May 15, 2010. They have serial numbers ranging from 042-10000 through 102-09335.

According to Nidek, the company is in the process of notifying all distributors and customers about the recall through both email and regular mail and has reached the owners of 95% of the affected devices.

The FDA recommends that consumers notify their equipment provider if they have an affected product in their home or place of business. The company has said they can continue to use the device while waiting for a replacement for the defective capacitor.

Consumers with questions can call Nidek Medical Products, Inc. at 1-2050856-7200 ext 242, or can contact the company by email at fieldcorrection@nidekmedical.com.