Apparatus, Gas-scavenging
Anesthesiology · 21 CFR 868.5430
Recent MDR events
9 adverse event reports on file
- NitroNox Plus Scavenger PlusJul 31, 2026OtherMW6000235
- NitroNox Plus Scavenger PlusJul 31, 2026OtherMW6000236
- SERVO-I BASE UNITAug 29, 2025MalfunctionMaquet Critical Care Ab8010042-2025-0001341
- DEMISTIFIER 2000CAug 20, 2020MalfunctionPeace Medical0002243990-2020-00001
- DEMISTIFIERMay 11, 2020MalfunctionPeace Medical, Inc.10042701
- SERVO EVAC 180Feb 24, 2015MalfunctionMaquet Critical Care Ab8010042-2015-00078
- CUTTING LOOPOct 22, 2012InjuryGyrus Acmi, Inc.3006159227-2012-00011
- AIRCARE SOURCE CONTROL AIRATORJul 25, 1997MalfunctionApotheus Laboratories, Ltd.1649397-1997-00002
- AIRCARE SOURCE CONTROL AIRATORJul 22, 1997MalfunctionApotheus Laboratories, Ltd.1649397-1997-00001
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Arcing of Electrodes”
No history to chart.
Recalls
5 recall events for this product code
- Dynasthetics LLCOpen, ClassifiedMay 16, 2023
Vapor-Clean, Part Number 111AU
Due to a manufacturing issue that may result in filter leakage.
Z-1591-2023 · View FDA record ↗ - Maquet Cardiovascular Us Sales, LlcTerminatedFeb 27, 2015
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.
Z-1224-2015 · View FDA record ↗ - Datex-Ohmeda IncTerminatedJul 20, 2004
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine
Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
Z-0967-04 · View FDA record ↗ - Datex-Ohmeda IncTerminatedJul 20, 2004
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.
Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
Z-0968-04 · View FDA record ↗ - Datex-Ohmeda IncTerminatedJul 20, 2004
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magn
Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
Z-0969-04 · View FDA record ↗
Registered firms
20 firms currently registered for this product code
Hda Technology, Inc.
Lake Forest, CA, US
Precision Fluidics Division Parker Hannifin Corp.
HATFIELD, PA, US
Dynasthetics
Salt Lake City, UT, US
Carestream Medical
Sanford, FL, US
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Peace Medical, Inc.
Wharton, NJ, US
Accutron, Inc.
PHOENIX, AZ, US
Anesthesia Associates, Inc.
SAN MARCOS, CA, US
Teleflex Medical Llc
Morrisville, NC, US
Datex-ohmeda, Inc.
MADISON, WI, US
Icu Medical Healthcare Manufacturing S.a. De C.v.
Tijuana, B.C. C.P. Baja California, MX
Teleflex Medical De Tecate, S. De R.l De C.v.
TECATE Baja California, MX
Sedation Systems Llc
Tierra Verde, FL, US
Anecare Llc
SALT LAKE CITY, UT, US
510(k) clearances
43 clearances for this product code
- Parker Hannifin CorporationMar 5, 2023
K223452 · Nitronox Scavenger Plus
- Anesthetic Gas Reclamation, Inc.Dec 4, 2020
K193646 · Dynamic Gas Scavenging System 2 (DGSS - 2)
- Sedation Systems, LLCMay 5, 2017
K160950 · MINISCAV
- Teleflexmedical, Inc.Oct 30, 2014
K142138 · ISO-GARD MASK
- Teleflexmedical, Inc.Jan 9, 2014
K132729 · ISO-GARD MASK
- Teleflexmedical, Inc.Feb 14, 2013
K123176 · ISO-GARD CLEARAIR MASK
- G. Dundas Co.,Inc.Jun 23, 2011
K110930 · ACTIVE WASTE GAS SCAVENGER
- Axon Medical, Inc.Apr 16, 2010
K092031 · VAPOR-CLEAR, MODEL 100