The Recall Desk
SevereFDA (Devices)·Z-1627-2025·Announced 2025-05-07

GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure

GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c anesthesia delivery systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which per the rubric requires a severity score of at least 4. The device is an anesthesia delivery system with a failure mode that could result in inadequate patient ventilation, posing a risk of serious injury or death during surgical or critical care procedures.

Plain-English summary

GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems because they may not provide effective ventilation when used in Volume Control Ventilation (VCV) mode. The affected units were manufactured by GE Medical Systems China Co., Ltd. and distributed worldwide, including nationwide in the United States and Puerto Rico, as well as in numerous countries across Europe, Asia, Africa, and the Americas.

The recall affects 383 units identified by specific serial numbers and GTIN 00195278439536. The affected model is the Carestation 620 A1, Model/REF Number 1012-9620-200, along with other Carestation 620/650/650c and 750/750c systems that share the same ventilation software issue.

In VCV mode, these anesthesia systems may fail to deliver adequate tidal volumes, potentially resulting in inadequate patient ventilation during surgery or critical care. Effective ventilation can still be achieved using Pressure Control Ventilation (PCV), Pressure Control Ventilation Volume Guarantee (PCV-VG), or manual ventilation modes.

Healthcare facilities and users should immediately discontinue use of the affected systems in VCV mode and switch to PCV, PCV-VG, or manual ventilation. Facilities should contact GE Healthcare to arrange for a software update or service correction. Users should also report any adverse events or concerns to the FDA.

The recalled product

Product
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Anesthesia Delivery System
Hazard
Affected units
383

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • GTIN 00195278439536
  • Serial Numbers: SM624510015MD
  • SM624510016MD
  • SM624510017MD
  • SM624510018MD
  • SM624450001WD
  • SM624450002WD
  • SM624450003WD
  • SM624450004WD
  • SM624450005WD
  • SM624450006WD
  • SM624450007WD
  • SM624450008WD
  • SM624450009WD
  • SM624450010WD
  • SM623290016WD
  • SM623290017WD
  • SM624470034WD
  • SM624470035WD
  • SM624470036WD

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 15 recalled by GE Medical Systems China Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems China Co., Ltd.

See all →

Same hazard · ventilation failure

See all →