Carestation 650c A1Recalls & reported problems

Data updated Oct 16, 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 650c A1 is an anesthesia gas machine used in operating rooms. The 70 reports mostly describe battery and power failures — including failures during pre-use checkout that could interrupt mechanical ventilation — plus no gas flow, inadequate delivery, and inaccurate output. No deaths and no injuries were reported. Two open recalls name this device: one from November 2025 about unexpected shutdowns when mains power is lost, and one from March 2025 about ineffective 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: 70
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00840682103954), received between Jul 18, 2019 and Apr 29, 2026 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Failure to Run on Battery” (19 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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-1632-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

Failure to Run on Battery19
No Flow14
Therapeutic or Diagnostic Output Failure12
Power Problem10
Insufficient Flow or Under Infusion5
Electrical /Electronic Property Problem2
Failure to Power Up2
Inaccurate Delivery2

Patient problems

No Clinical Signs, Symptoms or Conditions66
No Known Impact Or Consequence To Patient2
No Patient Involvement2

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 29, 2026Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A BATTERY FAILURE THAT COULD RESULT IN A LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25033222 ↗
MalfunctionApr 29, 2026Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028726 ↗
MalfunctionApr 29, 2026Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028301 ↗
MalfunctionApr 28, 2026Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019073 ↗
MalfunctionApr 28, 2026Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25015075 ↗
MalfunctionApr 22, 2026Failure to Run on Battery; Power Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A POWER FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957319 ↗
MalfunctionApr 9, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN LOSS OF MECHANICAL VENTILATION DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835884 ↗
MalfunctionMar 16, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS AN ERROR 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 24607182 ↗
MalfunctionMar 11, 2026Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567750 ↗
MalfunctionFeb 16, 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 24342682 ↗
MalfunctionFeb 11, 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 24319772 ↗
MalfunctionFeb 11, 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 24313247 ↗
MalfunctionFeb 11, 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 24313205 ↗
MalfunctionFeb 6, 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 24276339 ↗
MalfunctionJan 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 24219853 ↗
MalfunctionJan 29, 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 24207186 ↗
MalfunctionJan 8, 2026Power Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A POTENTIAL UNIT POWER FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003856 ↗
MalfunctionDec 24, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN LOSS OF MECHANICAL VENTILATION DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23889145 ↗
MalfunctionDec 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THERE WAS AN ERROR 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 23848792 ↗
MalfunctionNov 20, 2025Power Problem; Power Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POTENTIAL POWER FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23609297 ↗
MalfunctionNov 18, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
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 23583671 ↗
MalfunctionNov 13, 2025Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23539997 ↗
MalfunctionNov 12, 2025Therapeutic or Diagnostic Output Failure; Therapeutic 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 23533750 ↗
MalfunctionNov 5, 2025Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476240 ↗
MalfunctionOct 21, 2025Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351941 ↗

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-1634-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
Z-1624-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
Z-1628-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
Z-1631-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
Z-1627-2025 · Mar 21, 2025 · Open, Classified
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. 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-2955-2018 · Jul 24, 2018 · Terminated
GE Carestation 30 anesthesia systems
Z-2954-2018 · Jul 24, 2018 · Terminated
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) 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	`00840682103954`
Brand	Carestation 650c
Model	A1
Catalog no.	1012-9655-000
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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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