ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator 의 리콜

Recall

37832

Class 2

Z-1006-2007

2007-04-23

2007-07-03

Terminated

United States

2010-12-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51799

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).

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)continuing use and safety information; and (4) contact information for requesting additional details. Patients are advised that they may continue to use their S8 flow generators until a replacement unit is provided. ResMed is instructing patients, sleep labs, and hospitals to continue using the device, placing it on a hard clean surface, with a clear area around the device. ResMed intends to replace the affected products with either a new device or a device in which the affected components have been replaced.