| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00075-1 |
| Product Name/Description |
Invacare PerfectO2 Oxygen Concentrator
(Provides supplemental oxygen to patients with respiratory disorders)
Model Numbers: IRC5PO2VAW, IRC5PO2AW
Serial Numbers Range: 10CSZ43XXXX - 12GSZ62XXXX
Manufactured between March 2010 to August 2012
Dianz capacitor date codes 2010.03. XD to 2012.08.XD
ARTG Number: 144033 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Invacare has become aware of five reported instances in the European Union in which the capacitor, an internal electrical component of the concentrator, ruptured which results in a potential fire hazard. Invacare has learned that the PSI (Pressure Sensitive Interrupter) design for the compressor motor start/run capacitor (an internal electrical component of the concentrator) by one supplier could lead to rupture. The 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. There were no injuries reported in any of the five instances. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Invacare is requesting customers to:
1. Examine their stock and quarantine any affected concentrator(s)
2. Inspect each impacted concentrator and if it contains a Dianz capacitor with date codes from 2010.03.XD (March, 2010) to 2012.08.XD (August, 2012) replace the capacitor using the recall replacement kit(s) 1131250 provided to the customer at no charge.
3. Upon completing the correction, quarantine and destroy all impacted capacitors. This action has been closed-out on 26/08/2016. |
| Contact Information |
1800 814 367 - Invacare |