Calculator, Pulmonary Function Data
Anesthesiology · 21 CFR 868.1880
Recent MDR events
67 adverse event reports on file
- VYNTUS BODY APSJan 8, 2026MalfunctionJaeger Medical Gmbh1000271197-0001-02026
- PRODUCT VYNTUS ONEMay 28, 2025MalfunctionJaeger Medical Gmbh9615102-2025-00172
- VYNTUS BODYApr 24, 2025MalfunctionVyaire Medical Gmbh9615102-2025-00171
- VYNTUS ONE USMar 17, 2025MalfunctionVyaire Medical Gmbh9615102-2025-00164
- PRODUCT VYNTUS ONE PFTNov 27, 2024MalfunctionVyaire Medical Gmbh9615102-2024-00160
- PRODUCT VYNTUS ONENov 22, 2024MalfunctionVyaire Medical Gmbh9615102-2024-00159
- PRODUCT VYNTUS ONENov 22, 2024MalfunctionVyaire Medical Gmbh3010838917-2024-00127
- PRODUCT VYNTUS BODYNov 21, 2024MalfunctionVyaire Medical Gmbh3010838917-2024-00126
- PRODUCT VYNTUS PNEUMONov 6, 2024MalfunctionVyaire Medical Gmbh9615102-2024-00158
- VYNTUS ONE PCSep 18, 2024MalfunctionVyaire Medical Gmbh9615102-2024-00155
Event type breakdown
Recalls
5 recall events for this product code
- Vyaire Medical, Inc.Open, ClassifiedMay 8, 2024
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample l
Potential of the nozzle separating during patient use.
Z-1730-2024 · View FDA record ↗ - Innovision A/STerminatedSep 8, 2016
Innocor Cardiopulmonary Exercise and Lung Function Testing System
The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use. The replacement is intended to prevent risk of electric shock.
Z-2769-2016 · View FDA record ↗ - Philips Healthcare Inc.TerminatedApr 8, 2010
Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product.
Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock.
Z-1274-2010 · View FDA record ↗ - Philips Healthcare Inc.TerminatedApr 8, 2010
Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product.
Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock.
Z-1275-2010 · View FDA record ↗ - Philips Healthcare Inc.TerminatedApr 8, 2010
REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product.
Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock.
Z-1291-2010 · View FDA record ↗
Registered firms
88 firms currently registered for this product code
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Pulmone Advanced Medical Devices, Ltd.
Raananna Central, IL
Philips North America Llc
Export, PA, US
Philips North America Llc
Murrysville, PA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Jaeger Medical America Inc.
Moreno Valley, CA, US
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
Isomedix Operations Inc.
Northborough, MA, US
Cortex Metabolic Inc.
Eatonton, GA, US
Vacumed, Div. Of Vacumetrics, Inc.
Ventura, CA, US
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Jaeger Medical Gmbh
HOECHBERG Bavaria, DE
Pulmone Usa Inc
Carrollton, TX, US
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Jones Medical Instrument Co.
OAK BROOK, IL, US
Futuremed America, Inc.
GRANADA HILLS, CA, US
510(k) clearances
90 clearances for this product code
- Techbopulm, Ltd.Sep 17, 2024
K240293 · STS
- Vyaire MedicalAug 23, 2019
K183567 · Vyntus/SentrySuite Product Line
- Vyaire Medical, Inc.Aug 16, 2019
K190853 · Vyntus BODY
- Vyaire Medical, Inc.Nov 30, 2018
K181524 · Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
- Cosmed SrlJun 20, 2017
K162515 · COSMED K5 Wearable Metabolic Technology
- Pulmone Advanced Medical Devices, Ltd.Oct 21, 2016
K161295 · MiniBox +
- Carefusion Germany 234 GmbHAug 14, 2015
K150810 · Vyntus / SentrySuite Product Line
- Carefusion Germany 234 GmbHAug 22, 2014
K133925 · VYNTUS/ SENTRYSUITE PRODUCT LINE