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Amazrock

AMAZROCK PTE. LTD. · Model Amaz-HC1001401 · UDI-DI 08883000001749

FLL

510(k) clearances

1,303

Adverse events (13 deaths)

Recalls

479

Facilities

Description

AMAZROCK Digital Infrared Thermometer Dual Mode supports temperature scan via Forehead or Eardrum Detection. It is designed for use with adults and children. Modern Design & Convenient to Use - Ergonometric design to facilitate easy use across all ages. - The back-light screen makes it very convenient to use at night or under dim lighting conditions. - Rapid and accurate reading with 1 second measurement time. - Forehead scan mode makes it convenient to measure temperature while your child is sleeping. - Eardrum temperature detection mode is only suitable for use for ages 3 months & above. - Easy & Comfortable use experience as compared with other thermometer(s). Simple operations with just 2 buttons - “Head” (Forehead temperature detection) or “Ear” (Eardrum temperature scan). - Supports 20 readings memory recall. - Comes with two AAA batteries for immediate use.

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Corporation	The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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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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.