Philips has experienced thousands of complaints, lawsuits, criminal investigations, and a potential DOJ settlement related to CPAP recalls.
GE Healthcare’s Recall of Ventilator Batteries Gets Class I Label from FDA Over Device Shutdown Risk
Due to their ability to cause the premature shutdown of GE Healthcare’s Carescape R860 ICU ventilators, the U.S. FDA has deemed GE Healthcare’s recall of more than 100,000 batteries as a Class 1 event—the most severe kind.Read More
Medtronic recalled its HeartWare Ventricular Assist Device System, which is designed to help the heart pump blood to the rest of the body.Read More
The U.S. FDA has identified the Dragonfly OpStar imaging catheter as a Class I recall, the most serious type of recall.Read More
The FDA updated a safety communication regarding medical device reports associated with the breakdown of materials used in Philips devices.Read More
Avanos Medical is experiencing an FDA Class I recall of its enteral access system due to reports of injuries and patient deaths.Read More
The FDA is proposing an order be issued that would require Philips Respironics to address recalled devices, including millions of ventilators.Read More