On November 18, 2022, DeVilbiss Healthcare voluntarily initiated an instruction manual correction for the 525 North America series oxygen concentrators, used to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The voluntary instruction manual correction will apply to all 525 North America series oxygen concentrators manufactured and distributed from January 1, 2015, through October 31, 2022. Reason for Instruction Manual Update 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. The evidence from post-market surveillance of nearly 10 years of product in the field suggests that the risk of injury from a patient touching an applied part and receiving a burn is extremely low. In cases related to wear components requiring maintenance during the service life of the product, the device contains visual and audible alarms that will advise the end user when such maintenance is required. Please follow the link below to access the full notice: DeVilbiss Instruction Manual Notice Please click on the link below to access the updated instruction manual: DeVilbiss Updated Instruction Manual | 
