Respironics REMstar heated CPAP humidifier
Medical device recall
23 November 2006
| Level: | Consumer |
|---|---|
| Class: | III |
| Reference: | RN-2006-0759 |
| Date agreed: | 23 November 2006 |
| Product: |
Respironics REMstar heated CPAP humidifier Serial numbers up to H239662 - manufactured between December 2001 and April 2003 only. |
| ARTG number: | 99688 |
| Sponsor: | The Mayo Group International Pty Ltd |
| Contact: | 1300 559 389 |
| Reason: | The design of the electrical power inlet to the humidifier is faulty. This may cause the humidifier to overheat the base of the AC inlet connection. |
Classification system:
Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.
Class I & II recalls are considered to be safety related recalls.
Content last updated: Thursday, 23 November 2006
Web page last updated: Thursday, 3 February 2011
URL: http://www.tga.gov.au/safety/recalls-device-remstar-061123.htm