Respironics REMstar heated CPAP humidifier
Medical device recall
| Level: | Consumer | Class: | III |
|---|---|---|---|
| Reference: | RN-2006-0759 | Date: | 23 November 2006 |
| Product: | Respironics REMstar heated CPAP humidifier | ||
| ARTG number: | 99688 | ||
| Serial numbers: | up to H239662 - manufactured between December 2001 and April 2003 only. | ||
| Sponsor: | The Mayo Group International Pty Ltd | ||
| Phone: | 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. | ||
| Letters are expected to be dispatched by the sponsor within two working days of the agreed date. Recall notices will appear in national newspapers from Tuesday 28 November 2006, | |||
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.