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Carestation 750 A1Recalls & reported problems

Datex-Ohmeda Inc · CARESTATION 750 A1 · Class 2

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

Quick summary

This Datex-Ohmeda Carestation 750 anesthesia machine has 2,202 reports, with no deaths and 3 injuries. Most describe the machine delivering no gas flow, and others describe output failures, electrical problems or mechanical problems. 2 recalls are open: one over a possible unexpected shutdown during AC power loss, and one over poor ventilation in volume control mode on certain models. Reports fell to 705 in the last 12 months from 1,308 in the previous 12.

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
2,204
Deaths reported
0
Injuries reported
3
Recalls naming it
2

Summary

The FDA's MAUDE database contains 2,204 adverse event reports that list this exact device (DI 00840682145596), received between Oct 5, 2023 and Sep 30, 2026 — classified as 3 injuries, 2,201 malfunctions.

The most frequently reported specific device problem is “No Flow” (1,425 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 6 reportsDec 2023: 16 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 7 reportsApr 2024: 39 reportsMay 2024: 14 reportsJun 2024: 12 reportsJul 2024: 17 reportsAug 2024: 23 reportsSep 2024: 21 reportsOct 2024: 24 reportsNov 2024: 23 reportsDec 2024: 21 reportsJan 2025: 26 reportsFeb 2025: 21 reportsMar 2025: 29 reportsApr 2025: 103 reportsMay 2025: 305 reportsJun 2025: 203 reportsJul 2025: 246 reportsAug 2025: 171 reportsSep 2025: 45 reportsOct 2025: 115 reportsNov 2025: 78 reportsDec 2025: 90 reportsJan 2026: 40 reportsFeb 2026: 102 reportsMar 2026: 90 reportsApr 2026: 152 reportsMay 2026: 94 reportsJun 2026: 32 reportsJul 2026: 4 reportsAug 2026: 4 reportsSep 2026: 21 reportsOct 2026: 0 reports202420252026305
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. 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-0914-2026 · Root cause: Component change control · FDA record ↗

  2. 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-1635-2025 · Root cause: Device Design · FDA record ↗

Most reported problems

Device problems

  • No Flow1,425
  • Therapeutic or Diagnostic Output Failure130
  • Insufficient Flow or Under Infusion117
  • Electrical /Electronic Property Problem110
  • Mechanical Problem97
  • Failure to Run on Battery81
  • Unexpected Therapeutic Results81
  • Power Problem49

Patient problems

  • No Clinical Signs, Symptoms or Conditions2,202
  • Low Oxygen Saturation2
  • Laceration(s)1

Recent adverse event reports

The 25 most recent of 2,204 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Therapeutic or Diagnostic Output Failure

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50949902 ↗
  • MalfunctionSep 30, 2026Failure to Run on Battery

    It was reported that there was a battery failure during pre-use checkout that could cause loss of mechanical ventilation. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946324 ↗
  • MalfunctionSep 30, 2026Failure to Run on Battery

    It was reported that there was a battery failure during pre-use checkout that could cause loss of mechanical ventilation. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946321 ↗
  • MalfunctionSep 30, 2026Failure to Run on Battery

    It was reported that there was a battery failure during pre-use checkout that could cause loss of mechanical ventilation. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946317 ↗
  • MalfunctionSep 30, 2026Insufficient Flow or Under Infusion

    It was reported that there was a malfunction resulting in prolonged insufficient oxygen (O2) concentration or fresh gas flow during pre-use checkout. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944158 ↗
  • MalfunctionSep 30, 2026Insufficient Flow or Under Infusion

    It was reported that there was a malfunction resulting in prolonged insufficient oxygen flow during pre-use checkout. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50944137 ↗
  • MalfunctionSep 29, 2026Therapeutic or Diagnostic Output Failure

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939360 ↗
  • MalfunctionSep 29, 2026Therapeutic or Diagnostic Output Failure

    It was reported that there was a failure to boot up the device, resulting in the inability to initiate mechanical ventilation during pre-use checkout. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50933810 ↗
  • MalfunctionSep 29, 2026Mechanical Problem

    It was reported that there was a malfunction during pre-use checkout resulting in loss of mechanical ventilation.There was no patient involvement reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50932186 ↗
  • MalfunctionSep 29, 2026Insufficient Flow or Under Infusion

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50932139 ↗
  • MalfunctionSep 29, 2026Unexpected Therapeutic Results

    It was reported that there was a malfunction during pre-use checkout resulting in unexpected therapeutic system performance.There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50931608 ↗
  • MalfunctionSep 28, 2026Insufficient Flow or Under Infusion

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50926442 ↗
  • MalfunctionSep 28, 2026Increase in Pressure

    It was reported that there was a malfunction during pre-use checkout resulting in excessive or prolonged pressure. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50914119 ↗
  • MalfunctionSep 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 50913448 ↗
  • MalfunctionSep 28, 2026Power Problem

    It was reported that there was a malfunction resulting in loss of unit power during pre-use checkout. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50913423 ↗
  • MalfunctionSep 25, 2026Failure to Run on Battery

    It was reported that there was a battery failure during pre-use checkout that could cause loss of mechanical ventilation. There was no patient involvement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50900161 ↗
  • MalfunctionSep 24, 2026Electrical /Electronic Property Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50888863 ↗
  • MalfunctionSep 24, 2026No Flow

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50882781 ↗
  • MalfunctionSep 24, 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 50882111 ↗
  • MalfunctionSep 24, 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 50881876 ↗
  • MalfunctionSep 6, 2026Insufficient Flow or Under Infusion

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50640408 ↗
  • MalfunctionAug 28, 2026Therapeutic or Diagnostic Output Failure

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50502892 ↗
  • MalfunctionAug 27, 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 50484263 ↗
  • MalfunctionAug 27, 2026Insufficient Flow or Under Infusion

    It was reported there was a malfunction during a case resulting in insufficient oxygen or fresh gas flow. There was no patient injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50474707 ↗
  • MalfunctionAug 19, 2026Therapeutic or Diagnostic Output Failure

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50326414 ↗

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-1637-2025 · Mar 21, 2025 · Open, Classified
    GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.

Other Gas-machine, anesthesia devices

All Gas-machine, anesthesia devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.