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INVOS PMC71V-GERecalls & reported problems

Covidien LP · GE CARESCAPE (TM) rSO2 - INVOS Parameter;For use with GE Patient Monitors · 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 10884521780729), received between Aug 5, 2022 and Aug 5, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K182868); they may or may not involve this specific model.

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 Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 5, 2022Low Readings; Low Readings

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT MEASURE CORRECTLY. THE LEFT SENSOR SIDE VALUE WAS FROZEN AT 15, WHILE ON THE OTHER SIDE THE VALUE WAS LOW AT 15. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15174662 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182868. One submission often covers many models, so check the product and lot details in each record.

  • Z-1732-2024 · Jan 9, 2024 · Open, Classified
    Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC

Other Oximeter, Tissue Saturation devices

All Oximeter, Tissue Saturation devices →

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