Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Nidek Medical Oxygen Concentrators

04 Jun 2012

The United States Food and Drug Administration (FDA) issued a Class I recall concerning Oxygen Concentrators manufactured by Nidek Medical Products with model numbers as follows [Serial numbers 042-10000 through 102-07044]:

  1. NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W.
  2. NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W.
  3. NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W.
  4. NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W.
  5. NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W.
  6. NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W.
  7. NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W.
  8. NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W.
  9. NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W.

According to the FDA, the reason of this recall was due to capacitor failure which may result in a fire hazard and loss of supplemental oxygen supply.

According to the local suppliers, the affected products have been distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted 4 June 2012

Back