Recall Z-1006-2007 ยท BZD Ventilator, Non-Continuous (Respirator)
Resmed Corporation
ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #33007.
| Date | Jul 3, 2007 (initiated Apr 23, 2007) |
| Status | Terminated |
| Reason | S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure, sparks, smoke). |
| Root cause | Other |
| Action | ResMed began to broadly distribute information regarding the recall on 4/23/2007. A press release was issued on 4/23/2007 with information regarding the recall and information was posted at ww.resmed.com/s8program. The firm is providing a Consignee notification package and press release to include(1) specific device names subject to the recall and affected serial numbers; specific information to be provided in each package to the end-customer. The specific information to the end user customers will include: (1) specific device names subject to the recall; (2) affected serial numbers; (3)cont |
| Quantity | 300,000 |
| Distribution | Worldwide, USA, Canada, and Mexico. |
| FDA record | Open on fda.gov |