FDA: ‘Carefully Monitor’ Philips CPAP Device for Overheating
The FDA received over 270 reports related to thermal issues such as fire, smoke, burns, and other signs of overheating while patients are using Philips DreamStation 2 CPAP machines.
The FDA received over 270 reports related to thermal issues such as fire, smoke, burns, and other signs of overheating while patients are using Philips DreamStation 2 CPAP machines.
The ventilators contain power management printed circuit board assemblies that were distributed by a third-party warehouse and do not meet ventilator standards, per a safety communication.
Philips has reached an agreement to resolve all economic loss claims related to Philips Respironics’ recall of certain respiratory care and sleep devices.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Read MoreThe recall is due to a container defect that may result in failure to deliver the recommended dose.
Read MoreThe FDA is providing information on oxygenator devices used in extracorporeal circulation following a recall notice by Getinge/Maquet.
Read MoreDraeger Medical is recalling the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits after finding that glued connections may loosen before or during ventilation due to a manufacturing error.
Read MoreApproximately 500,000 tests—which the FDA has “significant concerns” of bacterial contamination—were distributed to CVS Health, as well as about 16,000 tests to Amazon.
Read MoreThe US FDA is warning consumers to not purchase certain “alertness” and “energy boost” products, due to concerns they contain ammonia.
Read MoreThe recommendations come in response to questions about existing inventory the FDA says it has received from healthcare provider organizations that rely upon O&M Halyard surgical N95 respirators.
Read MoreThe FDA says it has been made aware of laboratory test results that show certain models of surgical N95 respirators, surgical masks, and pediatric face masks do not meet quality and performance expectations and may not provide expected fluid barrier protection to the wearer.
Read MoreThe recall pertains to certain reworked DreamStations that also were recalled in June 2021.
Read MoreThe revision states that the vaccine can cause thrombosis with thrombocytopenia syndrome, which may be life-threatening.
Read MorePatient oxygen desaturation events can occur when the Life2000 ventilation system is connected with a third-party oxygen concentrator, the FDA says.
Read MoreThe FDA issued marketing denial orders for two Vuse menthol e-cigarette products: the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%.
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