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Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices due to Due to Interruptions and/or Loss of Therapy
Philips Respironics, Inc. is updating the use instructions for V30, A30, and A40 ventilators due to a failure in the Ventilator Inoperative alarm, which can cause interruption or loss of therapy.
Interruption or loss of therapy may lead to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients.
This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact Philips Respironics, Inc. at 1-800-345-6443 and select prompt 4 then 5, or via email at respironics.clinical@philips.com.
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