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.
FDA Recall Z-0577-2015 · Posted 2014-12-12
Advertisement
Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeCAW
Date Initiated2014-09-23
Date Terminated2015-06-18
Product Quantity5,963
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement