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Invivo 101759Recalls & reported problems

Philips Ds North America LLC · 1.5T KFA with coil ID · Class 2

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 00884838081529), received between Mar 28, 2019 and Mar 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (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

  • Thermal Decomposition of Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMar 28, 2019Thermal Decomposition of Device

    KNEE COIL CAME INTO SERVICE AS A NORMAL ROUTINE REPAIR WITH NO INDICATIONS OF HEATING OR PATIENT INVOLVEMENT. DURING THE REPAIR PROCESS, INVIVO TECHNICIAN DISCOVERED THE HOUSING OF THE COIL WAS WARPED (FROM HEATING) IN AN AREA THAT WOULD BE IN CONSTANT CONTACT WITH THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8461396 ↗

Other Coil, magnetic resonance, specialty devices

All Coil, magnetic resonance, specialty devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.