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ESOTEST MULTI PATIENT CABLE

FIAB SPA · Model F5417/US · UDI-DI 08054953344010

FLL Prescription
1
510(k) clearances
1,321
Adverse events (13 deaths)
18
Recalls
479
Facilities

Description

The patient cable, F5417/US is the component of ESOTEST MULTI which connects the main unit to the disposable temperature probe ESOTEST MULTI Probe. The F5417/US is supplied with the 30115 ESOTEST MULTI MONITOR. The handle at one end of the cable contains both the electronic circuits which digitize the temperatures and the components that make ESOTEST MULTI immune to the effects of a defibrillator discharge and other EMC disturbances. An 18 contact custom socket on one side of the handle allows the user to connect the ESOTEST MULTI to a mapping system using the ESOTEST MULTI Adapter Cable. The F5417/US is supplied with the ESOTEST MULTI MONITOR 30115. The ESOTEST MULTI Patient Cable (F5417/US model number) is supplied togheter with the ESOTEST MULTI MONITOR (30115 model number) for the use of the ESOTEST Multi probe ( 2617376H/US and 2615358H/US model numbers).

Recalls

DateFirmReason
2025-09-17Baxter Healthcare CorporationAffected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, w
2024-06-13Baxter Healthcare CorporationThe Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
2021-07-20Welch Allyn IncIf 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
2019-10-28Cardinal Health 200, LLCThe 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 (
2019-10-28Cardinal Health 200, LLCThe 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 (
2019-10-28Cardinal Health 200, LLCThe 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 (
2019-10-28Cardinal Health 200, LLCThe 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 (
2019-10-28Cardinal Health 200, LLCThe 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 (
2018-02-02Philips Consumer LifestyleDevice may provide inaccurate measurements.
2017-10-173M Company - Health Care BusinessDuring 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.