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Continuous Measurement Thermometer
FDA product code FLL · Class 2 · General Hospital
0
Registered devices
1,636
Adverse events
19
Recalls
798
510(k) clearances
Devices with this code
THERMOFLASH — VISIOMED GROUPPolygreen — Dongguan Polygreen Technology Co., Ltd.Lutech — LUTECH INDUSTRIES INCCaring Mill — Caring MillFoster & Thrive — MCKESSON CORPORATIONActherm — Dongguan Actherm Medical Corp.Welch Allyn, Inc. — WELCH ALLYN, INC.Rite Aid — 180 INNOVATIONS LLCDeRoyal — DEROYAL INDUSTRIES, INC.Phoenix Healthcare Solutions LLC — PHOENIX HEALTHCARE SOLUTIONS, LLCFamidoc — FAMIDOC USA, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.ADVANCED VITAL SIGNS MONITOR — ADVANCED INSTRUMENTATIONS, INC.FMT — METKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIDiagnostix™ — AMERICAN DIAGNOSTIC CORPHealthSmart — D-M-S HOLDINGS, INC.Unimed — Unimed Medical Supplies, Inc.Tyto Device — TYTO CARE LTDAvalon Toco+ Transducer — Philips Medizin Systeme Böblingen GmbHBerrcom — Guangzhou Berrcom Medical Device Co., LtdDirect Supply — Mediana.CO.LTDTemperature Probe — Edan Instruments, Inc.Adtemp™ — AMERICAN DIAGNOSTIC CORPFamily Wellness — Family Dollar Stores
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-20 | DeRoyal Industries Inc | Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle. |
| 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| The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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. |
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