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The review was triggered by Philips’ international recall of its ventilators, CPAP and BiPAP devices due to risks posed by the soundproofing material. Read More
Users were advised to remove the affected ventilators from service and quarantine them pending a replacement of the printed circuit board assembly by the company. Read More
“Quality issues are common events in the lifecycle of medical devices, especially during the production ramp-up phase,” said the company’s CEO. Read More
Smiths Medical has received three complaints alleging deaths and seven complaints for serious injury due to malfunctions of its Medfusion pumps that it was slow to act on, the FDA said in a warning letter. Read More
Cardiac perforations associated with Medtronic’s Micra leadless pacemakers are more likely to be associated with “serious complications, such as cardiac tamponade or death,” the FDA said. Read More
An FDA inspection of a Philips Respironics facility in Pennsylvania has turned up problems that will delay the company’s replacement of millions of its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. Read More
The reason for the recall of certain lots of Ellume’s COVID-19 Home Tests, totaling more than 2.2 million individual tests in all, is that they have a higher-than-acceptable rate of false-positive test results. Read More