Recall Z-0872-2015— Invacare Corporation

Name: FDA recall Z-0872-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-31

Class II · Terminated

Class II FDA medical device recall by Invacare Corporation, initiated 2014-10-31, terminated 2017-02-07. It names one FDA 510(k) clearance: K020386. Product: Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.. Reason: The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard..

Recalling firm: Invacare Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-10-31
Terminated: 2017-02-07
Firm location: Elyria, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K020386 — INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02Invacare Corp.·cleared 2002-07-02

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

Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.

Reason for recall

The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.

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