About the Recall:
DeVilbiss Healthcare is voluntarily implementing this correction to replace the instruction manual with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. DeVilbiss Healthcare decided to initiate this correction after reviewing the current standard and identifying the clarifications needed.
Risk to Health
This voluntary instruction manual correction should not affect patients, health care providers, or other persons who are exposed to the device. The risk to an end user arises from the potential to touch an applied part that exceeds 41°C, which may result in a burn. However, a combination of extreme conditions must take place concurrently to create this potential hazard, and there is a low likelihood of this type of event occurring. There have been no specific complaints or adverse events related to this voluntary correction.
Actions to be taken by the Customer
Disregard the current instruction manual and replace it with the updated version. You may obtain a copy by contacting your Home Medical Equipment provider directly, or by accessing the dedicated instruction manual update website at
www.recallrtr.com/525series. To download a copy or order a hard copy, select the option ‘Purchased from Other/Concentrator User’.
