Sv70 Ventilator
Anesthesiology · 21 CFR 868.5895
Recent MDR events
47,855 adverse event reports on file
- RespironicsJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-114848
- RespironicsJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-114849
- RespironicsJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-114850
- BiPAP A40Jul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040844
- Bipap A40 ProJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040801
- Bipap A40 ProJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040800
- Bipap A40 ProJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040799
- RespironicsJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-114851
- RespironicsJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-114854
- RespironicsJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-114853
Event type breakdown
Recalls
64 recall events for this product code
- Philips Respironics, Inc.Open, ClassifiedJul 2, 2025
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
This device does not indicate for use in patients with respiratory failure.
Z-2037-2025 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedMay 24, 2024
BiPAP A40 Ventilators:
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Z-1813-2024 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedSep 28, 2023
Philips Respironics V60/V60 Plus Ventilator,
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Z-2631-2023 · View FDA record ↗ - DRE Medical Group IncOpen, ClassifiedJun 29, 2023
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breath
Devices 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 may be contaminated.
Z-2025-2023 · View FDA record ↗ - Respironics California, LLCOpen, ClassifiedApr 18, 2022
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617,
Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
Z-0907-2022 · View FDA record ↗ - Respironics California, LLCOpen, ClassifiedApr 18, 2022
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
Z-0908-2022 · View FDA record ↗ - Respironics California, LLCOpen, ClassifiedApr 18, 2022
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
Z-0909-2022 · View FDA record ↗ - Respironics California, LLCOpen, ClassifiedFeb 25, 2022
Philips Respironics V60 Ventilator Part Number 1053617
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Z-0662-2022 · View FDA record ↗ - Respironics California, LLCOpen, ClassifiedFeb 25, 2022
Philips Respironics V60 Plus Ventilator Part Number 1138747
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Z-0663-2022 · View FDA record ↗ - Respironics California, LLCOpen, ClassifiedJan 22, 2021
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient ci
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Z-0902-2021 · View FDA record ↗
Registered firms
61 firms currently registered for this product code
Ceva Logistics Limited
Daventry Northamptonshire, GB
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Respironics Deutschland Gmbh & Co.kg
Herrsching Bavaria, DE
Fisher & Paykel Healthcare S.a.de C.v.
Tijuana Baja California, MX
Plexus Electronica S. De R.l. De C.v..
Zapopan Jalisco, MX
Mekics Co., Ltd.
Paju-si Gyeonggi, KR
Resmed Pty Ltd.
BELLA VISTA New South Wales, AU
Fisher & Paykel Healthcare, Ltd.
EAST TAMAKI Auckland, NZ
Nihon Kohden Orangemed, Llc
Santa Ana, CA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Resmed Corp
San Diego, CA, US
Fisher & Paykel Healthcare, Inc.
IRVINE, CA, US
Shenzhen Mindray Bio-medical Electronics Co.,ltd
SHENZHEN Guangdong, CN
Breas Medical, Inc.
N Billerica, MA, US
Maquet Critical Care Ab
SOLNA Stockholm, SE
Galemed (xiamen) Co., Ltd.
XIAMEN Fujian, CN
510(k) clearances
25 clearances for this product code
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Apr 6, 2026
K252182 · SV70 Ventilator (SV70)
- Mekics Co., Ltd.May 15, 2025
K242931 · HFT750U
- Breas Medical ABDec 13, 2024
K240779 · Vivo 3
- Fisher & Paykel Healthcare, Ltd.Aug 9, 2024
K233643 · F&P Airvo 3 NIV (PT311US)
- Maquet Critical Care ABJul 6, 2023
K230173 · Servo-air Lite Ventilator System
- Nihon Kohden Orangemed, Inc.Jul 1, 2022
K213521 · Nihon Kohden NKV-330 Ventilator System
- Fisher & Paykel Healthcare LimitedMar 9, 2020
K191624 · F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
- Fisher and Paykel Healthcare LimitedAug 24, 2017
K170367 · Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small