Infinity Gamma XXL MS18852Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049098050067), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K070566); 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.

• InjuryJul 27, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT A PATIENT WAS BEING MONITORED WITH A DRAEGER INFINITY GAMMA XXL PATIENT MONITOR CONNECTED TO THE DRAEGER INFINITY CENTRALSTATION (ICS). ECG AND HF CHANGES OCCURRED, THE PATIENT BECAME BRADYCARDIC. ALARMS OF HF AND SPO2 DISCONNECTION WERE NOT AUDIBLE. AN ALERT WAS GIVEN FOR ARRHYTHMIA VIA THE ASYSTOLE ALARM. THE PATIENT WAS SUCCESSFULLY REANIMATED.

  Patient problems: Bradycardia

  MAUDE report 17410211 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070566. One submission often covers many models, so check the product and lot details in each record.

• Z-0281-2012 · Oct 31, 2011 · Terminated
  Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).
• Z-3048-2011 · Jul 29, 2011 · Terminated
  Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside a
• Z-3047-2011 · Jul 29, 2011 · Terminated
  Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and tr
• Z-2284-2010 · Jun 4, 2010 · Terminated
  Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
• Z-2283-2010 · Jun 4, 2010 · Terminated
  Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
• Z-0582-2010 · Nov 9, 2009 · Terminated
  Delta/Delta XL Monitors with Omega S Package