The FDA updated a safety communication regarding medical device reports associated with the breakdown of materials used in Philips devices.
Philips is scrutinizing a recall of its ventilators and respiratory devices from the U.S. FDA.Read More
Despite Philips getting the green light from the U.S. FDA to start repairing and replacing ventilators impacted by the company’s class 1 recall, the FDA exposed a possible safety risk concerning a replacement component.Read More
The U.S. FDA is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines.Read More
A software error has prompted a Class I recall of the Zimmer Biomet Rosa One Brain platform, a robotic system that helps neurosurgeons position tools and implants during brain surgery.Read More
Timely medical device recalls can prevent serious patient injury and even death; however, critics say that the FDA’s uncoordinated, paper-based system can delay critical recall communications for months, resulting in the continued use of potentially dangerous products.Read More
The U.S. FDA has issued a Class I recall on Medtronic’s wireless insulin pump remote controllers. The FDA notified patients of the recall—the most serious type—because of problems with the devices that could cause serious injury or death.Read More