Recall Z-1631-2025— GE Medical Systems China Co., Ltd.

Name: FDA recall Z-1631-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-21

Class I · Ongoing

Class I FDA medical device recall by GE Medical Systems China Co., Ltd., initiated 2025-03-21. It names one FDA 510(k) clearance: K151570. Product: GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Reason: GE HealthCare has become aware that 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..

Recalling firm: GE Medical Systems China Co., Ltd.
Classification: Class I
Status: Ongoing
Initiated: 2025-03-21
Firm location: Wuxi, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K151570 — Carestation 620/650/650CDatex-Ohmeda, Inc.·cleared 2016-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200

Reason for recall

GE HealthCare has become aware that 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.