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Geratherm SolarTherm Speed Digital Thermometer

R.G. ENTERPRISES (U.S.A.), INC. · Model Retail SolarTherm Digital Thermomete · UDI-DI 00614801400534

FLL
1
510(k) clearances
1,321
Adverse events (13 deaths)
18
Recalls
480
Facilities

Description

SolarTherm Speed digital flex tip thermometer is white with blue accent colors and is used to measure body temperatures orally, rectally or axillary. The temperature measuring range is from 89.6°~111.0°F. If the reading is below 89.6°F, the letter L will be displayed indicating Low reading. If the reading is above 111.0°F, the letter H will be displayed indicating High reading. Energy is supplied using an integrated solar cell with approximately 25 temperature readings within 60-minutes before a recharge is needed. There is an audible beeping for 8 seconds after peak temperature is reached, built-in memory recall enabling display of the previously measured and automatic shut-off in about 9 minutes. Prior to using the solar cell must be exposed to a light source at least 3 hours. This may be in room light or sunlight. A half circle symbol will appear in the display when the solar cell needs to be recharged. Turn the power off before recharging, the solar cell should face the light source during recharging and for ongoing use store on counter top where thermometer is exposed to light throughout the day. A clear plastic cover is provided.

Recalls

DateFirmReason
2025-09-17Baxter Healthcare CorporationAffected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, w
2024-06-13Baxter Healthcare CorporationThe Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
2021-07-20Welch Allyn IncIf 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
2019-10-28Cardinal Health 200, LLCThe 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 (
2019-10-28Cardinal Health 200, LLCThe 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 (
2019-10-28Cardinal Health 200, LLCThe 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 (
2019-10-28Cardinal Health 200, LLCThe 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 (
2019-10-28Cardinal Health 200, LLCThe 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 (
2018-02-02Philips Consumer LifestyleDevice may provide inaccurate measurements.
2017-10-173M Company - Health Care BusinessDuring 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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Data 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.