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Ozeri
COMMONPATH LLC · Model TH1-BL · UDI-DI 00815817014153
10
510(k) clearances
1,303
Adverse events (13 deaths)
18
Recalls
479
Facilities
Description
The Thermometer can display the result in either Fahrenheit or degree Celsius. Colour - Black How to use: Steady and smoothly scroll the wheel either back and fourth or in one direction, so as to travel 12 inches or 30 cm. The scrolling will kinetically charge the device. Continue scroll the wheel until the LCD ON. Position the thermometer at the distance of less than 1 inch for the center of the patients eyebrows. Press and release the measure button.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-17 | Baxter Healthcare Corporation | Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, w |
| 2024-06-13 | Baxter Healthcare Corporation | The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU). |
| 2021-07-20 | Welch Allyn Inc | If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the us |
| 2019-10-28 | Cardinal Health 200, LLC | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( |
| 2019-10-28 | Cardinal Health 200, LLC | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( |
| 2019-10-28 | Cardinal Health 200, LLC | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( |
| 2019-10-28 | Cardinal Health 200, LLC | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( |
| 2019-10-28 | Cardinal Health 200, LLC | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( |
| 2018-02-02 | Philips Consumer Lifestyle | Device may provide inaccurate measurements. |
| 2017-10-17 | 3M Company - Health Care Business | During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.