Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a
FDA device recall Z-0577-2015 · posted 2014-12-12 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- CAW
- Quantity affected
- 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.
- Date initiated
- 2014-09-23
- Date posted
- 2014-12-12
- Date terminated
- 2015-06-18
- Location
- Elyria, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 (K020386) | Invacare Corp. | 2002-07-02 |