Nidek Medical Products’ Recall of Nuvo Lite Oxygen Concentrators Deemed Class I

Nidek Medical Products’ Recall of Nuvo Lite Oxygen Concentrators Deemed Class INidek Medical Products Inc. just issued a recall of its Nuvo Lite Oxygen Concentrators, the U.S. Food & Drug Administration (FDA) announced. The recall has been deemed a Class I by the agency, which means that this is a situation in which there exists a reasonable probability that the use of or exposure to a violative, recalled product will cause serious adverse health consequences or death.

The Nidek Medical Products’ oxygen concentrator models involved in the recall are:

  • Nidek Medical Mark5 Nuvo / M5C5 Std,  115 V ~60Hz – 410W
  • Nidek Medical Mark5 Nuvo / M5C5 Std,  230 V ~50/60Hz – 420W
  • Nidek Medical Mark5 Nuvo / M5C5 OCSI,  115 V ~50/60Hz – 410W
  • Nidek Medical Mark5 Nuvo / M5C5 OCSI,  230 V ~50/60Hz – 420W
  • Nidek Medical Mark5 Nuvo 8 Std,  115 V ~60Hz – 500W
  • Nidek Medical Mark5 Nuvo 8 OCSI,  230 V ~50/60Hz – 420W
  • Nidek Medical Mark5 Nuvo Lite Model 520 Std,  115 V ~60Hz – 330W
  • Nidek Medical Mark5 Nuvo Lite Model 525 OCSI,  115 V ~60Hz – 330W
  • Nidek Medical Mark5 Nuvo Lite Model 920 Std,  230 V ~60Hz – 330W
  • Nidek Medical Mark5 Nuvo Lite Model 925 OCSI,  230 V ~50Hz – 300W
  • Nidek Medical Mark5 Nuvo Lite Model 925/60 OCSI,  230 V ~60Hz – 280W

The recall was implemented following capacitor-related fires in Medical Mark5 Nuvo Lite Oxygen concentrators. The recalled devices were manufactured and distributed from January 2004 through May 2010 and involve serial numbers in the range of 042-10000 through 102-09335. The capacitor component inside the concentrators failed in some instances, resulting in residential and nursing home fires and loss of supplemental oxygen supply. To date. There have been no reports of injury.

The oxygen concentrators are normally used to supply supplemental oxygen to patients within a home setting and are not considered to be life-supporting devices.

Nidek Medical Products, Inc., is in the process of notifying all of its distributors and customers by email and regular mail, as needed, and is also arranging to supply replacement capacitors for the affected devices, as available. Recipients of more than 95% of the recalled concentrators have been notified.

The firm advises customers to notify their equipment providers if they have a recalled Nuvo Lite Oxygen Concentrator in their home or place of business; patients may continue to use the recalled medical device while waiting for a correction. Nidek Medical Products, Inc. can be reached at 1.205.856.7200 ext 242 or by email at fieldcorrection@nidekmedical.com.

Adverse reactions related to these recalled devices should be reported to the FDA at 1.800.FDA.1088 or online at http://www.fda.gov/safety/Medwatch/HowToReport/default/htm to obtain a form to fax or mail.

This entry was posted in Defective Medical Devices and tagged . Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.