INFINITY GAMMMA XL MS18985Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049098003865), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive Result” (1 report).

1 other recall cover devices cleared under the same FDA submission (K053484); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 25, 2023False Positive Result; Output Problem; False Positive Result; Output Problem

  IT WAS REPORTED THAT ¿AT THE T2-10 SITE, WE SEDATED THE RISK PATIENT SOMEWHAT. THE SATURATION METER IN THE CARDIO VERSION VIBRATED AND STOPPED SHOWING THE READING VALUE. SHOWED A GOOD CURVE, BUT NO READING DURING THE ENTIRE SEDATION. IN THE END, A FINGER SENSOR WAS USED. IT WOULD HAVE BEEN IMPORTANT BECAUSE THE PATIENT WAS OBESE, STARTED BREATHING BADLY AND FAST. A CLEAR DANGER EVENT. IN ADDITION, AT THE SAME PLACE AND PLACE T2-9 HAS INCREASINGLY STARTED OCCUR THAT WHEN THE MONITOR IS ON, YOU DISCONNECT THE EKG AND PUT IT BACK ON, IT SHOWS A STRAIGHT GREEN LINE FOR QUITE A LONG TIME BEFORE STARTS SHOWING COMPLEXES SOMETIMES CAUSING ASY ALARMS FOR NOTHING. THERE IS A FIX FOR THE SPO2 ISSUE, SWITCHING TO ANOTHER TECHNIQUE. THIS WAS LEFT UNDONE EVEN DURING SUPERVISION FOR FINANCIAL REASONS.¿. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391685 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053484. One submission often covers many models, so check the product and lot details in each record.

• Z-0302-2007 · Nov 17, 2006 · Terminated
  Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.