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ESOTEST MULTI MONITOR

FIAB SPA · Model 30115 · UDI-DI 08054953344003

FLL Prescription

510(k) clearances

1,321

Adverse events (13 deaths)

Recalls

480

Facilities

Description

The ESOTEST MULTI Monitor is a device for measuring the esophageal temperature through the ESOTEST MULTI Probe, which contains up to seven independent thermal sensors. The cable which connects the main body of the monitor to the probe is called ESOTEST MULTI Patient Cable. With ESOTEST MULTI Monitor it is possible to follow, in an immediate and precise way, the evolution of the temperature inside the esophagus. When an alarm is triggered, the system generates sound and visual effects aimed at getting the attention of the operator. The measured temperatures and the alarm conditions (if any) can be stored in the internal memory of the monitor and examined at a later time on the monitor itself or on an external personal computer (after exporting the corresponding data to an USB mass storage device). The ESOTEST MULTI MONITOR (30115 model number) is supplied togheter with the ESOTEST MULTI Patient Cable (F5417/US model number) for the use of the ESOTEST Multi probe ( 2617376H/US and 2615358H/US model numbers).

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The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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