Z-0577-2015Class II

Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part...

Name: Z-0577-2015 Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part...
Creator: Invacare Corporation
Published: 2014-09-23
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2014-09-23 / Terminated / root cause: manufacturing process

FDA source

Invacare Corporation began a recall of 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... on 2014-09-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0577-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-23
Posted: 2014-12-12
Terminated: 2015-06-18
Recalling firm: Invacare GmbH
Product: 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.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 5,963
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 codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0577-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0577-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09

Product code CAW

K020386Class IIInvacare Platinum, Models Irc 5Lx and Irc 5Lx02Invacare Corp. / cleared 2002-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)