SENSITHERM MULTI
FIAB SPA · Model ST-PROBE-7 · UDI-DI 08058480753994
FLL
Prescription
1
510(k) clearances
1,303
Adverse events (13 deaths)
18
Recalls
479
Facilities
Description
ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm) and a total length of 83 cm (usable length 75 cm) that is used for monitoring the internal temperature of the esophagus. The probe is equipped with 7 steel rounded electrodes. Each electrode contains a thermocouple for the independent detection of the esophageal temperature.
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| The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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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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.