The FDA today said it expanded its recall of Draeger Medical‘s Evita V500 and Babylog VN500 ventilators to include the optional PS500 batteries after they were updated with new power supply firmware that failed to correct the issue depleting the battery. The original recall, initiated last September and updated in December, put the ventilators on […]
The FDA today issued a recall for Dräger Medical‘s emergency transport ventilators over a system error that can lead to a a halt in ventilator function, labelling the recall as Class I. The FDA labels recalls as Class I, the agency’s most serious classification of recall, when there is a reasonable probability that product use […]
The FDA Wednesday issued a recall notice for Draeger Medical‘s Evita V500 and Babylog VN500 ventilators due to an issue with the batteries not appropriately displaying its charge. The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that […]
Pennsylvania device maker Draeger Medical recalled a pair of its ventilators after discovering battery issues that could put patient safety at risk.
A trio of medical device makers collected Pentagon supply deals worth a collective $234.3 million, according to recent Defense Dept. reports.
Nine medical device companies ranging from industry titans to small-cap movers inked a pledge to make the data generated by their devices available to patients, in a move aimed at ridding the healthcare system of unnecessary deaths by 2020.
Sorin Group (BIT:SRN) reported flat sales but strong profit growth for 2011, saying it raised earnings by 48.3% and revealing that the cardiac rhythm management slump has made its way across the pond.
The Italian medical device maker posted net income of €58.0 million (~$75.2 million) on sales of €743.4 million (~$963.4 million) for the year ended Dec. 31, 2011. That compares with profits of €39.1 million (~$50.7 million) on sales of €745.8 million (~$966.5 million) during 2010.
HeartWare International (NSDQ:HTWR) reported strong sales growth amid widening losses for the 4th quarter and 2011, and Wall Street showed some love.
The Framingham, Mass.-based heart pump maker raked in $82.8 million for the year ended Dec. 31, 2011, a 50% bump from $55.2 million in 2010. Losses, however, widened to $55.1 million, or $3.94 per diluted share. Analysts had forecast a loss of $3.17 per diluted share for 2011.
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Draeger Medical’s Infinity Acute Care system, used to monitor patient vital signs and therapy, got a Class I recall from the FDA over concerns that its weight-based drug dosage calculator may make dangerously high recommendations.
The system may even recommend a dose as much as 10 times higher than that the safe amount, and "may cause serious adverse health consequences, including death," according to the FDA.
In addition, the Infinity system’s electrocardiogram and blood pressure monitors may displaying DATA with a 5 or 10 second delay.