Carestation 750c A1Recalls & reported problems

Datex-Ohmeda Inc · CARESTATION 750c A1 · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

The Carestation 750c A1 is a GE HealthCare (Datex-Ohmeda) anesthesia machine that delivers breathing support and gases during surgery. The 39 reports filed since June 2024 mostly describe the machine failing to deliver gas or breathing volume, stopping unexpectedly, or not running on battery power, with no deaths or injuries mentioned. Two open recalls name this device: one started November 2025 for possible shutdown when mains power is lost, and one started March 2025 for machines that do not provide effective ventilation in volume control mode.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 39
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00840682146425), received between Jun 4, 2024 and Sep 30, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “No Flow” (16 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K213867); 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Nov 14, 2025Class IOpen, Classified
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Z-0914-2026 · Root cause: Component change control · Recall details · FDA record ↗
Mar 21, 2025Class IOpen, Classified
Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
Z-1637-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

No Flow16
Therapeutic or Diagnostic Output Failure6
Electrical /Electronic Property Problem3
Failure to Run on Battery3
Insufficient Flow or Under Infusion3
Mechanical Problem2
Failure to Power Up1
Gas/Air Leak1

Patient problems

No Clinical Signs, Symptoms or Conditions39

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Improper Flow or Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951768 ↗
MalfunctionMay 7, 2026No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110021 ↗
MalfunctionApr 27, 2026No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001895 ↗
MalfunctionApr 21, 2026No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942222 ↗
MalfunctionApr 2, 2026No Flow
THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE THAT INDICATES IT MAY BE IMPACTED BY A CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025 (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765385 ↗
MalfunctionApr 2, 2026No Flow
THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE THAT INDICATES IT MAY BE IMPACTED BY A CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025 (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765352 ↗
MalfunctionMar 26, 2026No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698876 ↗
MalfunctionMar 26, 2026No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025). THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698874 ↗
MalfunctionMar 17, 2026No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24614489 ↗
MalfunctionFeb 24, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN SYSTEM IS NOT SWITCHING ON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430818 ↗
MalfunctionFeb 17, 2026No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24361752 ↗
MalfunctionFeb 12, 2026No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326506 ↗
MalfunctionJan 6, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN BELLOWS FAILURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23976076 ↗
MalfunctionNov 20, 2025No Flow; No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025). THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23601818 ↗
MalfunctionOct 24, 2025No Flow; No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378418 ↗
MalfunctionAug 27, 2025Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POWER FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22906936 ↗
MalfunctionJul 17, 2025No Flow; No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22528204 ↗
MalfunctionJul 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT OXYGEN OR FRESH GAS FLOW AND THE DEVICE DID NOT AUTOMATICALLY SWITCH TO ALT O2. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22472033 ↗
MalfunctionJun 10, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN SIB FAILURE RESULTS IN SYSTEM MALFUNCTION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22178939 ↗
MalfunctionMay 8, 2025No Flow; No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (GEHC FIELD ACTION NUMBER 34142) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21982884 ↗
MalfunctionMay 8, 2025No Flow; No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (GEHC FIELD ACTION NUMBER 34142) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21982695 ↗
MalfunctionMay 7, 2025No Flow; No Flow
AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (GEHC FIELD ACTION NUMBER 34142) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21975065 ↗
MalfunctionMar 31, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN POWER MANAGEMENT BOARD FAILURE THAT DOES NOT ALLOW THE BATTERY TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21729472 ↗
MalfunctionMar 28, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN POWER MANAGEMENT BOARD FAILURE DURING A CASE THAT DOES NOT ALLOW THE BATTERY TO CHARGE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21724095 ↗
MalfunctionMar 19, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN UNEXPECTED THERAPEUTIC SYSTEM PERFORMANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21646736 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213867. One submission often covers many models, so check the product and lot details in each record.

Z-0915-2026 · Nov 14, 2025 · Open, Classified
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Z-1635-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.

Device details

UDI-DI	`00840682146425`
Brand	Carestation 750c
Model	A1
Company	Datex-Ohmeda Inc
Product code	BSZ · Gas-machine, anesthesia
Class	Class 2
FDA submission	K213867
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Apr 12, 2023

Device type (GMDN): Anaesthesia workstation, general-purpose

An assembly of electronic devices used for general inhalation anaesthesia (i.e., the delivery of oxygen (O2), nitrous oxide (N2O), other medical gases, and anaesthetic agents) and possibly total intravenous anaesthesia and local anaesthesia. Its main components are high, intermediate, and low pressure gas delivery systems, a breathing circuit (typically with a ventilator), and an anaesthetic gas scavenging system (AGSS). It has built-in alarms, analysers, control/monitoring systems, and typically has integrated circuitry/touchscreen displays for target controlled anaesthesia (TCA) for any type of patient (e.g., neonate, adult).

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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