CARESCAPE Monitor B650Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682105200), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 death.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K131223); 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 18, 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.

• DeathDec 19, 2025Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm

  A PATIENT WAS BEING MONITORED WITH THE CARESCAPE B650 WHEN IT WAS REPORTED THAT THE PATIENT WAS FOUND IN ASYSTOLE, BUT THE DEVICE WAS NOT ALARMING AS EXPECTED. THE PATIENT DID NOT SURVIVE.

  Patient problems: Insufficient Information

  MAUDE report 23849803 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131223. One submission often covers many models, so check the product and lot details in each record.

• Z-2340-2018 · May 25, 2018 · Open, Classified
  GE Healthcare CARESCAPE Monitor B650
• Z-1606-2015 · May 4, 2015 · Terminated
  GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
• Z-2085-2014 · Jun 13, 2014 · Terminated
  GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
• Z-1175-2014 · Feb 28, 2014 · Terminated
  GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in