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The FDA’s Center for Devices and Radiological Health is proposing to issue an order requiring Philips Respironics to submit a plan to repair, replace or refund the purchase price of a range of recalled respiratory devices that it manufactured after November 2015. Read More
“False-positive or false-negative results from improper use of these tests could lead to further exposure of uninfected individuals,” the agency said. Read More
Customers who don’t have access to an appropriate sterilization method should stop using the devices and return them to the manufacturer, the FDA said. Read More
The FDA’s supervision of device safety is in the congressional crosshairs following last June’s recall of Medtronic’s HeartWare Ventricular Assist Device (HVAD) System. Read More