Philips recalls certain V60 vents
By HME News Staff
Updated 12:39 PM CDT, Thu August 5, 2021
AMSTERDAM – Philips has issued a recall for its V60 and V60 Plus ventilators equipped with high-flow therapy software versions 3.00 and 3.10 due to the risk of patients receiving reduced oxygen. The number of such devices recalled in the U.S.: 16,535. V60 and V60 Plus ventilators equipped with high-flow therapy are used to provide patients with breathing assistance at high concentrations of oxygen at a higher flow than typical oxygen therapy. These devices include a design safety mechanism limiting the amount of flow that can be delivered to a patient in situations where the system pressure reaches a default maximum pressure limit, due to a partial obstruction in the breathing circuit. If the issue causing maximum system pressure is not resolved by the health care provider, the ventilator will continue to provide the patient with lower oxygen flow rate and issue a low priority alarm. This could lead to serious adverse events, including death. There have been 61 incidents, 25 injuries and no deaths reported related to this issue. On June 18, Philips sent an “Urgent Field Safety Notice” letter to all affected customers and providing instructions when using the device for high-flow oxygen therapy. The recall for the V60 and V60 Plus vents with high-flow therapy software is separate and unrelated to another recall in June of certain CPAP/BiPAP machines and other vents.
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