Recalls

Overview

Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen

Recall Information
FDA
Health Canada RA-75939

Device Use: V60 and V60 Plus ventilators equipped with high flow therapy are used to provide patients with breathing assistance at high concentration 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.

Reason for Recall: Philips Respironics is recalling the V60 and V60 Plus ventilators that provide High Flow Therapy (Software Version 3.00 and Software Version 3.10) due to the risk to the patients who rely on the ventilator to provide high flow oxygen therapy if the system pressure reaches the default maximum limit. This can occur if the oxygen flow is partially blocked for any reason. 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.

For more details, please visit:
FDA:   https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-v60-and-v60-plus-ventilators-equipped-high-flow-therapy-software?utm_medium=email&utm_source=govdelivery

Health Canada: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75939r-eng.php