Recall Of Device For Critically Ill Newborns High-Risk Class I, FDA Says
The GENOSYL DS Nitric Oxide Delivery System was recalled by Vero Biotech because the device’s software could deliver an incorrect dosage of nitric oxide, a drug used on newborns experiencing respiratory failure.
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From Recalls To Clinical Trials, Medtronic’s Developing A ‘Systematic Approach’ To Capturing Patient Input
The medtech behemoth is putting in place a company-wide framework to make sure the voice of the patient is heard across the firm’s premarket and postmarket activities.
The US agency has announced three additional webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the coronavirus.
Stryker Corp. regulatory expert Ommeed Shahrokh explains the device giant’s decision-making process around product recalls and describes what’s included in recall letters to customers.