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TekCare Infrared Thermometer
AVITA CORPORATION · Model TS46 · UDI-DI 04710953421314
10
510(k) clearances
1,321
Adverse events (13 deaths)
19
Recalls
481
Facilities
Description
The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
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| The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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.