Carestation 650 A1Recalls & reported problems

Data updated Oct 13, 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

This Datex-Ohmeda Carestation 650 is an anesthesia gas machine. Its 3,102 reports mostly describe no gas flow, failure to run on battery, and output and power failures. The reports include 1 injury. There are 2 open recalls, covering possible unexpected shutdowns and poor ventilation in some modes. Reports fell in the most recent year (862) from the year before (1,393).

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: 3,109
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 3,109 adverse event reports that list this exact device (DI 00840682103947), received between Feb 2, 2018 and Sep 30, 2026 — classified as 1 injury, 3,108 malfunctions.

The most frequently reported specific device problem is “No Flow” (980 reports).

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

12 other recalls cover devices cleared under the same FDA submission (K151570); 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Recalls naming this device

Nov 14, 2025Open, 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-0913-2026 · Root cause: Component change control · FDA record ↗
Mar 21, 2025Open, 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-1628-2025 · Root cause: Device Design · FDA record ↗

Most reported problems

Device problems

No Flow980
Failure to Run on Battery427
Therapeutic or Diagnostic Output Failure422
Mechanical Problem254
Power Problem221
Electrical /Electronic Property Problem173
Insufficient Flow or Under Infusion164
Unexpected Therapeutic Results101

Patient problems

No Clinical Signs, Symptoms or Conditions3,011
No Patient Involvement69
No Consequences Or Impact To Patient15
No Known Impact Or Consequence To Patient6
Patient Problem/Medical Problem2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Capsular Contracture1
Chills1

Recent adverse event reports

The 25 most recent of 3,109 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955025 ↗
MalfunctionSep 30, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954933 ↗
MalfunctionSep 30, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949545 ↗
MalfunctionSep 30, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948961 ↗
MalfunctionSep 30, 2026Therapeutic or Diagnostic Output Failure
It was reported that there was an error during pre-use checkout resulting in loss of mechanical ventilation.There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945862 ↗
MalfunctionSep 30, 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 50942991 ↗
MalfunctionSep 30, 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 50942935 ↗
MalfunctionSep 29, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940613 ↗
MalfunctionSep 29, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932851 ↗
MalfunctionSep 29, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931809 ↗
MalfunctionSep 28, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926701 ↗
MalfunctionSep 28, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917593 ↗
MalfunctionSep 28, 2026Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917537 ↗
MalfunctionSep 28, 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 50914004 ↗
MalfunctionSep 28, 2026Excess Flow or Over-Infusion
It was reported that there was a malfunction resulting in high CO2 delivery during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913455 ↗
MalfunctionSep 27, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910421 ↗
MalfunctionSep 27, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910410 ↗
MalfunctionSep 27, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910409 ↗
MalfunctionSep 25, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906078 ↗
MalfunctionSep 25, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906032 ↗
MalfunctionSep 25, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904389 ↗
MalfunctionSep 25, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902920 ↗
MalfunctionSep 25, 2026Therapeutic or Diagnostic Output Failure
It was reported that there was a malfunction resulting in loss of mechanical ventilation during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895783 ↗
MalfunctionSep 25, 2026Power Problem
It was reported that there was a malfunction resulting in power up problem causing loss of ventilation during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895771 ↗
MalfunctionSep 25, 2026Therapeutic or Diagnostic Output Failure
It was reported that there was a malfunction resulting in loss of mechanical ventilation. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895587 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151570. 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-1632-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
Z-1624-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
Z-1627-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
Z-1634-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
Z-1631-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
Z-0813-2020 · Nov 25, 2019 · Terminated
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric
Z-2954-2018 · Jul 24, 2018 · Terminated
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Z-2955-2018 · Jul 24, 2018 · Terminated
GE Carestation 30 anesthesia systems
Z-2956-2018 · Jul 24, 2018 · Terminated
GE 9100c NXT anesthesia systems
Z-0579-2018 · Oct 11, 2017 · Open, Classified
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Z-2703-2017 · May 2, 2017 · Terminated
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

Device details

UDI-DI	`00840682103947`
Brand	Carestation 650
Model	A1
Catalog no.	1012-9650-000
Company	Datex-Ohmeda Inc
Product code	BSZ · Gas-machine, anesthesia
Class	Class 2
FDA submission	K151570
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jul 6, 2018

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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