| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00383-1 |
| Product Name/Description |
Invacare Platinum Oxygen Concentrator
Model Number : IRC9LXO2AWQ , IRC5LX02AW, IRC5LXAW
ARTG number: 144033 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Invacare has learned that the PSI (Pressure Sensitive Interrupter) design for the compressor motor start/run capacitor (Dianz brand)could lead to rupture. That capacitor in the oxygen concentrator has an internal pressure relief component (the PSI) which may not operate as intended permitting the capacitor to rupture in certain circumstances. If the PSI does not function to relieve the heat and pressure due to a short circuit within the capacitor, then the pressure can cause a rupture in the seam between the housing and the end plate. If the rupture occurs, the oil may be expelled from the capacitor which may result in a fire hazard. These capacitors were utilised in production from March 2010 to August 2012 at one of our manufacturing sites. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Invacare is providing instruction on how to identify if an affected capacitor is present in the oxygenator. If present end users are requested to contact their distributor to arrange for a technician to replace the capacitor. |
| Contact Information |
1800 814 367 - Invacare |