Carestation 620 A1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,015 adverse event reports that list this exact device (DI 00840682103985), received between Jan 26, 2018 and Sep 30, 2026 — classified as 2,015 malfunctions.

The most frequently reported specific device problem is “No Flow” (626 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.

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-0913-2026 · 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-1624-2025 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,015 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Run on Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952637 ↗
• MalfunctionSep 30, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952634 ↗
• MalfunctionSep 30, 2026Failure to Run on Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951793 ↗
• MalfunctionSep 30, 2026Therapeutic or Diagnostic Output Failure

  It was reported that there was a malfunction resulting in an error that results in an inability to initiate mechanical ventilation during pre-use checkout. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950509 ↗
• MalfunctionSep 30, 2026Failure to Run on Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949640 ↗
• MalfunctionSep 30, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949267 ↗
• MalfunctionSep 30, 2026Unexpected Therapeutic Results

  It was reported that there was a malfunction resulting in an allegation of high or excessive CO2 during pre-use checkout. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948675 ↗
• MalfunctionSep 30, 2026Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945261 ↗
• MalfunctionSep 29, 2026Failure to Run on Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939512 ↗
• MalfunctionSep 29, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939287 ↗
• MalfunctionSep 29, 2026Failure to Run on Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938071 ↗
• MalfunctionSep 29, 2026Failure to Run on Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938066 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  It was reported that there was a malfunction during pre-use checkout resulting in potential loss of O2. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931808 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931642 ↗
• MalfunctionSep 29, 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 50928117 ↗
• MalfunctionSep 28, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50919281 ↗
• MalfunctionSep 28, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917656 ↗
• MalfunctionSep 28, 2026Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914067 ↗
• MalfunctionSep 28, 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 50913842 ↗
• MalfunctionSep 28, 2026Insufficient Flow or Under Infusion

  It was reported that there was a malfunction resulting in insufficient O2 during pre-use checkout. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913435 ↗
• MalfunctionSep 25, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905970 ↗
• MalfunctionSep 25, 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 50904069 ↗
• MalfunctionSep 25, 2026Leak/Splash

  It was reported that there was a malfunction potentially resulting in a leak greater than 4.5 LPM. There was no report of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899316 ↗
• MalfunctionSep 25, 2026Power Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897636 ↗
• MalfunctionSep 25, 2026Therapeutic or Diagnostic Output Failure

  It was reported there was an error that results in an inability to initiate mechanical ventilation. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895572 ↗

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-1628-2025 · Mar 21, 2025 · Open, Classified
  GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
• Z-1634-2025 · Mar 21, 2025 · Open, Classified
  GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
• Z-1632-2025 · Mar 21, 2025 · Open, Classified
  GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. 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-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