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.
Enforcement
- Recall Number
- Z-0577-2015
- Event ID
- 69441
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Invacare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 17, 2014
- Initiation Date
- September 23, 2014
- Classification Date
- December 9, 2014
- Termination Date
- June 18, 2015
- Address
- 1200 Taylor St, N/A, Elyria, OH, 44035-6248, United States
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.
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.
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)
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.
5,963