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Ameritus 175-sRecalls & reported problems

Kentec Medical, Inc. · 175-s small size hydrogel probe cover · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10817522010175), received between Jul 17, 2018 and Jul 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Readings” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Low Readings1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 17, 2018Low Readings

    CUSTOMER STATES THAT ON 2 OCCASIONS, THE THERMAL PROBE COVER HAS CAUSED FALSE LOW SKIN TEMPERATURE READINGS AND INCREASED THE ISOLETTE TEMPERATURE, THUS ELEVATING THE PATIENT'S INTERNAL BODY TEMPERATURE. THE ACTUAL TEMPERATURE PROBE IS PRIMARILY RESPONSIBLE FOR TEMPERATURE READINGS, SO IT IS CURRENTLY UNKNOWN IF THE PROBE IS NOT TO BE AT FAULT FOR THESE INCIDENCES. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY PRODUCT FOR INVESTIGATION/ANALYSIS, AND IT IS UNKNOWN IF THE PRODUCT WILL EVENTUALLY BE RETURNED. AT THIS TIME, INVESTIGATION HAS NOT COMMENCED, AWAITING MORE INFORMATION FROM THE CUSTOMER. THIS TYPE OF COMPLAINT ON THIS DEVICE IS EXTREMELY RARE.

    Patient problems: No Information

    MAUDE report 7693923 ↗

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Sources and updates

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