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Why are you doing this recall?

ResMed announced a voluntary replacement program for certain of its S8 flow generators as a precaution against the remote potential for a short circuit in the devices’ power supply connector, a component manufactured by a third party supplier.

We are taking this voluntary action because we believe it is in the best interests of our customers and the patients who rely on our Tuotteet in order to maintain their good health and quality of life. This means it is also in the best interest of ResMed as a company.

Are patients at risk?

Patients may continue to use their S8 flow generators affected by this replacement program until they receive their replacement devices. To date, no significant property damage or patient injury has been reported.

How do I know if my device is part of the replacement program?

In order to determine whether your S8 flow generator is among the affected devices, you will need to check both the part number and the serial number. Both of these numbers are located on the name plate on the bottom of the device.

Part numbers included in the replacement program are:

  • 33007 (S8 Escape)
  • 33021 (S8 Elite)
  • 33030 (S8 Compact)
  • 33112 (S8 AutoSet Vantage)

Serial number ranges included in the replacement program are:

Alkaen Asti
20040285613 20060269563
20060284896 20060285445
20060287568 20060294694
20060312361 20060312597
20060318692 20060319459
20060325074 20060327695
20060330588 20060331043

How do I locate the device’s part number and serial number?

The 5-digit part number and the 11-digit serial number can be found on the bottom of the device. Before turning your device over, please be sure to unplug the device and detach your humidifier, if you have one.

Both the part number and the serial number are located at the bottom of the name plate under the bar code.

Is there a risk of using oxygen?

Patients should not use supplemental oxygen with an affected device and should immediately contact their home healthcare provider for a replacement.

How do patients receive their new S8 device?

Most patients will receive notification from their medical equipment supplier on how to obtain a new S8 flow generator.

Who can I call if I have additional questions?

We encourage you to call the ResMed S8 Replacement Call Centre at 888-899-8991. Outside of the U.S. or Canada, please visit www.resmed.com/s8program to find your local call Centre numbers.  You can also speak with your medical Tuotteet supplier.