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ESOTEST PROBE

FIAB SPA · Model 26155S/US · UDI-DI 08054242441925

FLL Prescription

510(k) clearances

1,303

Adverse events (13 deaths)

Recalls

479

Facilities

Description

ESOTEST Probe is an esophageal lead made of an external isolating cover in medical polyurethane Ø 7 French (2,3mm), total length 95 cm (usable length 75 cm) that is used for monitoring the internal temperature of esophagus tube. It is equipped with 5 steel rounded electrodes, each of the three intermediate electrodes is connected to a thermocouple for independent detection of esophageal temperature. The distal and the proximal electrodes are connected to auxiliary outlets through which, in case of need, they can be connected to other (recording) devices providing the output as an electrical signal. The distal end has a rounded-off tip, made a-traumatic by a special silicone cover. ESOTEST Probe is equipped with a trapezoidal connector box (“yoke”) made of ABS plastic, its main purpose is connection of probe to the monitor for the continuous recording of temperature, connection is realized by 3 miniature sockets that are embedded in the box. ESOTEST System is intended for continue esophageal temperature monitoring and it consists of 3 components: Monitor (ESOTEST ULTRA 30112 model number) , Interconnect cable (F5406/ULTRA model number) and Probe.

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The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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