CARESCAPE CENTRAL STATION MAI800 (REF 5867474-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195278343383), received between Feb 2, 2026 and Feb 2, 2026 — classified as 1 death.

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

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K162012); 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.

Recalls naming this device

1. Jul 30, 2026Class IIOpen, Classified

   Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.

   Z-3143-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Sep 5, 2025Class IIOpen, Classified

   Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.

   Z-0214-2026 · Root cause: Software design · Recall details · FDA record ↗

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.

• DeathFeb 2, 2026No Audible Alarm

  IT WAS REPORTED THAT A PATIENT WAS FOUND UNRESPONSIVE AND THE CENTRAL STATION MAY NOT HAVE AUDIBLY ALARMED. THE PATIENT WAS TRANSFERRED TO THE ICU WHERE THEY EVENTUALLY EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 24240085 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162012. One submission often covers many models, so check the product and lot details in each record.

• Z-0213-2026 · Sep 5, 2025 · Open, Classified
  GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube
• Z-1265-2022 · May 10, 2022 · Open, Classified
  CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices:
• Z-0808-2022 · Jan 28, 2022 · Open, Classified
  GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
• Z-0487-2018 · Jan 11, 2018 · Terminated
  GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This