Oximeter, Ear
Cardiovascular · 21 CFR 870.2710
Recent MDR events
114 adverse event reports on file
- LNCS TC-I REUSABLE EAR SENSORNov 13, 2025MalfunctionMasimo - 15750 Alton Pkwy3019388613-2025-00155
- OXIWEARNov 22, 2024MalfunctionOxiwearMW5162888
- TRUSATAug 9, 2022InjuryCritikon De Mexico S. De R.l. De C.v.3008729547-2022-00004
- TRUSATJul 8, 2022MalfunctionCritikon De Mexico S. De R.l. De C.v.3008729547-2022-00002
- MASIMOSET LNCS TC-I SPO2 REUSABLE EAR SENSORJun 14, 2021Injury11990730
- TOSCA SENSOR 92Jun 26, 2019InjuryRadiometer Basel Ag3002807968-2019-00027
- M-LNCS TC-IJun 12, 2019MalfunctionMasimo - 40 Parker2031172-2019-00283
- RD SET TC-IDec 20, 2018MalfunctionMasimo - 40 Parker2031172-2018-00581
- RD SET TC-IJul 6, 2018MalfunctionMasimo - 40 Parker2031172-2018-00376
- SENTEC V-SIGNApr 27, 2018MalfunctionImagenix, Inc7468483
Event type breakdown
Recalls
12 recall events for this product code
- GE Healthcare Finland OyOpen, ClassifiedJul 7, 2023
TruSignal Adult/Pediatric Sensor; Oximeter, Ear:
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Z-2026-2023 · View FDA record ↗ - GE Healthcare Finland OyOpen, ClassifiedJul 7, 2023
TruSignal AllFit Sensor:
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Z-2027-2023 · View FDA record ↗ - GE Healthcare Finland OyOpen, ClassifiedJul 7, 2023
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Z-2028-2023 · View FDA record ↗ - GE Healthcare Finland OyOpen, ClassifiedJul 7, 2023
TruSignal Wrap Sensor, REF TS-W-D; Oximeter
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Z-2029-2023 · View FDA record ↗ - GE Healthcare Finland OyOpen, ClassifiedJul 7, 2023
TruSignal Ear Sensor, REF TS-E-D; Oximeter
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Z-2030-2023 · View FDA record ↗ - GE Healthcare Finland OyOpen, ClassifiedJul 7, 2023
TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Z-2031-2023 · View FDA record ↗ - GE Healthcare Finland OyOpen, ClassifiedJul 7, 2023
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Z-2032-2023 · View FDA record ↗ - GE Healthcare Finland OyOpen, ClassifiedJul 7, 2023
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Z-2033-2023 · View FDA record ↗ - GE Healthcare Finland OyOpen, ClassifiedJul 7, 2023
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Z-2034-2023 · View FDA record ↗ - GE Healthcare, LLCTerminatedSep 14, 2011
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare)
The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety. Potential for system or components to start on fire or explode (general case).
Z-3206-2011 · View FDA record ↗
Registered firms
156 firms currently registered for this product code
Masimo Corporation
Irvine, CA, US
Industrial Vallera De Mexicali, S. A. De C. V.
Mexicali Mexico, MX
Ge Medical Systems Information Technologies
EL PASO, TX, US
Ge Medical Systems (china) Co., Ltd.
WUXI Jiangsu, CN
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US
Masimo Corporation
Irvine, CA, US
Cbr Enterprise Limited
Hong Kong, HK
Salaera, Llc D.b.a Maxtec
Salt Lake City, UT, US
Murata Vios, Private Limited
Kodihalli, Bangalore Karnataka, IN
Measurement Specialties Chengdu
Chengdu Sichuan, CN
Philips Medical Systems Ltda
Varginha Minas Gerais, BR
Isomedix Operations Inc.
SAN DIEGO, CA, US
Ge Medical Systems Information Technologies - Critikon De Mexico S. De R.l. De C.v.
JUAREZ Chihuahua, MX
Buffalo Office
Buffalo, NY, US
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
510(k) clearances
11 clearances for this product code
- Elekon Industries U.S.A., Inc.Dec 6, 2004
K042675 · FLEXI-STAT SP02 EAR SENSOR
- Datex-Ohmeda, Inc.Sep 2, 2004
K040831 · DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
- Epic Medical Equipment Services, Inc.Oct 17, 2001
K012333 · FLEXI-SITE SP02 EAR SENSOR
- Epic Medical Equipment Services, Inc.Mar 23, 2001
K010718 · FLEXI-SITE SP02 EAR SENSOR
- Nellcor, Inc.Oct 17, 1994
K944760 · DURA-Y OXYGEN TRANSDUCER, EAR CLIP
- Marquette Electronics, Inc.Sep 2, 1994
K942752 · MARQUETTE EAR PROBE SENSOR
- Fitness Quest, Inc.Jan 31, 1992
K914595 · PULSE RATE MONITOR
- Draeger Medical, Inc.Sep 11, 1986
K862426 · PULSE OXIMETER