FDA Issues Update on Most Serious Recall for Certain Ventilators

FDA Issues Update on Most Serious Recall for Certain Ventilators

The Food and Drug Administration (FDA) issued a notice warning that medical ventilators made by Philips Respironics are still under a Class I recall due to the potential for serious injury or death. The agency noted that the recall notice for the company’s V30, A30, and A40 ventilators, which are used for obstructive sleep apnea (OSA), primarily “involves correcting devices and does not involve removing them from where they are used or sold.” So…

FDA issues most serious recall for certain ventilators

The Food and Drug Administration has identified a Class I recall of Philips Respironics V30, A30 and A40 ventilators due to the potential for serious injury or death. The company is updating use instructions due to the risk of failure in the ventilator inoperative alarm, which can cause therapy interruption or loss. The recall involves correcting the devices and does not call for removing them from where they are used or sold.