Home › A.M.G. Médicale Inc › Accuflex5 VU Thermometer, from Physio Logic
Accuflex5 VU Thermometer, from Physio Logic
A.M.G. Médicale Inc · Model 016-651 · UDI-DI 00057565166511
10
510(k) clearances
1,636
Adverse events (13 deaths)
19
Recalls
477
Facilities
Description
Accurate readings in as little as 5 seconds. •Color feverline alert indicates if the reading is normal or if it represents a mild or high fever. •Large, backlit screen displays temperature in °C or °F. •Beeps when reading is complete. •Professional accuracy within 0.1°C (0.2°F). •Waterproof gentle–flex tip for added comfort & safety. •Recalls last reading. •Can be used orally, rectally, under the arm or to take bath water temperature. •Auto shut-off for extended battery life
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 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| The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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. |
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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.