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Sv70 Ventilator

FDA product code MNT · Class 2 · Anesthesiology

516
Registered devices
47,854
Adverse events
64
Recalls
25
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-05-09Philips Respironics, Inc.This device does not indicate for use in patients with respiratory failure.
2024-03-26Philips Respironics, Inc.Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxem
2023-08-25Philips Respironics, Inc.Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
2023-05-15DRE Medical Group IncDevices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices ma
2022-02-28Respironics California, LLCVentilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to ope
2022-02-28Respironics California, LLCVentilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to ope
2022-02-28Respironics California, LLCVentilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to ope
2022-01-24Respironics California, LLCA limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, w
2022-01-24Respironics California, LLCA limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, w
2021-06-18Respironics California, LLCIt has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.