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Continuous Measurement Thermometer
FDA product code FLL · Class 2 · General Hospital
4,312
Registered devices
1,303
Adverse events
18
Recalls
798
510(k) clearances
Devices with this code
DeRoyal — DEROYAL INDUSTRIES, INC.Unimed — Unimed Medical Supplies, Inc.HemoSphere Vita — Edwards Lifesciences LLCMyocardial Needle Temperature Probe — GENESEE BIOMEDICAL, INC.Veridian — VERIDIAN HEALTHCARE LLCUnimed — Unimed Medical Supplies, Inc.Filac — Cardinal Health, Inc.Spu GP Temp Probe Adult 3.0m — Drägerwerk AG & Co. KGaADeRoyal — DEROYAL INDUSTRIES, INC.infrared thermometer — Shenzhen Jumper Medical Equipment Co.,Ltd.THERMOFLASH — VISIOMED GROUPUnimed — Unimed Medical Supplies, Inc.Safety 1st — DOREL JUVENILE GROUP, INC.Temperature Probe — Edan Instruments, Inc.Safety 1st — DOREL JUVENILE GROUP, INC.Diagnostix™ — AMERICAN DIAGNOSTIC CORPDiagnostix™ — AMERICAN DIAGNOSTIC CORPTIDI — TIDI PRODUCTS, LLCAMPMED — AMPLIM, LLCUnimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Ampmed Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.Unimed — Unimed Medical Supplies, Inc.
Recent 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 th |
| 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| The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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 caus |
| 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 sta |
| 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 sta |
| 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 sta |
| 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 sta |
| 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 sta |
| 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 r |
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