Recall Z-1775-2012— Nidek Medical Products Inc

Name: FDA recall Z-1775-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-01

Class I · Terminated

Class I FDA medical device recall by Nidek Medical Products Inc, initiated 2012-05-01, terminated 2017-03-21. It names one FDA 510(k) clearance: K032509. Product: NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.. Reason: Capacitor failure may result in a fire hazard and loss of supplemental oxygen..

Recalling firm: Nidek Medical Products Inc
Classification: Class I
Status: Terminated
Initiated: 2012-05-01
Terminated: 2017-03-21
Firm location: Birmingham, AL, United States

510(k) clearances named in this recall

1 on FDA's record

K032509 — MARK 5 NUVO (M5C5)Nidek Medical Products, Inc.·cleared 2004-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.

Reason for recall

Capacitor failure may result in a fire hazard and loss of supplemental oxygen.

Data sourced from openFDA. This site is unofficial and independent of the FDA.