Events

Recall of Invacare Perfecto 2 V Oxygen Concentrator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69441
  • Event Risk Class
    Class 2
  • Event Number
    Z-0577-2015
  • Event Date Posted
    2014-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130540
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Generator, oxygen, portable - Product Code CAW
  • Reason
    It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.
  • Action
    Invacare sent an Urgent - Medical Device Recall letter to customers, dated October 2014. The letter identified the affected product as well as the problem involved. The letter instructed customers to examine their device and confirm that it has an affected serial number, or if service was conducted on the device using IRC5O2V Service Part Number 1165099 with the affected date codes. Customers were asked to immediately contact their dealer or service provider at the number listed, so that a replacement can provided. A service provider or dealer should be contacted with questions regarding the instructions.

Device

Invacare Perfecto 2 V Oxygen Concentrator
  • Model / Serial
    The defective sieve bed subassembly manufactured from 7/31/2014 to 8/19/2014 impacts the finished device- IRC5PO2V and Service Part Number-1165099.   The serial number range is as follows for the finished device:  14GF053772-14HF032124 (Sequential serial numbers)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, MI, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, IA, IN, and MS.
  • Product Description
    Invacare Perfecto 2 V Oxygen Concentrator || The finished device is packaged as a single unit. || The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. || Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA