According to a new recall announcement published by the U.S. Food and Drug Administration, the FDA has issued a Class I recall, its most severe type of recall, concerning Philips Respironics V60 and V60 Plus Ventilators. A Class I recall means that the recalled product may cause injury or death. The recall notice states that Philips Respironics V60 and V60 Plus ventilators’ expired adhesive could suddenly cause the affected ventilators to stop working with or without an alarm. The affected Philips Respironics V60 and V60 Plus Ventilators were distributed from July 29, 2021, to August 11, 2021, affecting 1,511 units.
The Philips Respironics V60 and V60 Plus ventilators were manufactured to aid patients during breathing difficulties. The ventilators provide mechanical ventilation for children and adults and children who are able to breathe on their own but have obstructive sleep apnea, respiratory failure, or chronic respiratory deficiency. The recalled ventilators are used in hospitals or other clinics under the direction of medical professionals.
Philips Respironics recalled certain V60 and V60 Plus ventilators due to a group of devices that were manufactured with expired adhesive. When the adhesive fails, a capacitor support bracket may become loose and may damage inner capacitors causing the ventilator to stop ventilating the patient. Moreover, when the units fail, they do not notify health care providers or fail to sound any warning alarm. Should a ventilator stop, the patient could be deprived of oxygen for an extended time, causing severe adverse health effects and/or death.
Currently, there have not been any reports of injuries, dangerous health consequences, or death connected to the recalled ventilators. Customers who have questions or concerns about the recall are urged to contact Philips Respironics Customer Care Solutions Center.
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