Draeger Breathing Filter Gets Class I Recall
The Draeger SafeStar 55 has been identified by the U.S. FDA as a Class I recall, the most serious type of recall.
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Canada Has a Massive Surplus of Unused Ventilators
The Canadian government’s response to ventilator needs of patients early during the pandemic resulted in an excessive equipment surplus.
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‘This is Not a Good Situation’: Philips Engineer Flagged Ventilator Foam Issues Years Before Recall, Court Docs Show
A year after Philips initiated a safety recall of its ventilators, it was discovered that the company had long been aware of certain issues.
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Dräger’s Breathing System Filter Recall Gets Class I Label from FDA After Ventilation Obstruction
Dräeger Medical, Inc. expanded on its voluntary recall of Lot LT2103 of Draeger SafeStar 55 Breathing System Filters.
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GE Healthcare’s Recall of Ventilator Batteries Gets Class I Label from FDA Over Device Shutdown Risk
Due to their ability to cause the premature shutdown of GE Healthcare’s Carescape R860 ICU ventilators, the U.S. FDA has deemed GE Healthcare’s recall of more than 100,000 batteries as a Class 1 event—the most severe kind.
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