Oximeter, Ear
FDA adverse event reports and recall history for oximeter, ear (product code DPZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 114
- Deaths
- 4
- Injuries
- 14
- Malfunctions
- 93
Reports per year
Source: FDA adverse event reports by year received, 2009–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-07-07Open, ClassifiedDevice Design
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
- 2023-07-07Open, ClassifiedDevice Design
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
- 2023-07-07Open, ClassifiedDevice Design
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.
- 2023-07-07Open, ClassifiedDevice Design
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.
- 2023-07-07Open, ClassifiedDevice Design
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.
- 2023-07-07Open, ClassifiedDevice Design
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.
- 2023-07-07Open, ClassifiedDevice Design
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.
- 2023-07-07Open, ClassifiedDevice Design
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.
- 2023-07-07Open, ClassifiedDevice Design
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.
- 2011-09-14TerminatedDevice Design
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).
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