Home › Device types › DPZ
Oximeter, Ear
FDA product code DPZ · Class 2 · Cardiovascular
181
Registered devices
114
Adverse events
12
Recalls
11
510(k) clearances
Devices with this code
CARESCAPE B850 — GE Healthcare Finland OyTruSignal SpO2 — GE Healthcare Finland OyNA — GE Healthcare Finland OyPatient Application Kit with Ear Clip for mature/intact skin — SenTec AGPSG Cable B — SenTec AGPSG Cable C — SenTec AGEar Sensor — Honeywell Healthcare Solutions GmbHMulti-Site Attachment Ring for mature/intact skin — SenTec AGTruSignal SpO2 — GE Healthcare Finland OyNA — GE Medical Systems Information Technologies, Inc.NA — GE Healthcare Finland OyNA — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.Ear Clip easy — SenTec AGtc Sensor 54 — Radiometer Medical ApSEar sensor — Honeywell Healthcare Solutions GmbHCARESCAPE B650 — GE Healthcare Finland OyTCM4x Cable — Radiometer Medical ApSElectrolyte 54 — Radiometer Medical ApSMembrane Changer (reloadable) / single unit — SenTec AGTruSignal SpO2 — GE Healthcare Finland OyContact Gel — SenTec AGElectrolyte 84 — Radiometer Medical ApSCARESCAPE Software — GE Healthcare Finland OyTOSCA Open end interface cable 5V FS — Radiometer Basel AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2011-04-08 | GE Healthcare, LLC | 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 safe |
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