Home / Recalls / GE Medical Systems China Co., Ltd. / Z-1626-2025

Z-1626-2025 Class I Ongoing

Recalled by GE Medical Systems China Co., Ltd. — Wuxi, N/A

Recall Details

Product Type
Devices
Report Date
May 7, 2025
Initiation Date
March 21, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27 units

Product Description

GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012

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.

Distribution Pattern

Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tonga, Trinidad Tobago, Tunisia, T¿rkiye, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.

Code Information

GTIN 00195278569677, Serial Numbers: SM624250018WC, SM624250019WC, SM624500025WC, SM624500026WC, SM624500027WC, SM624290020WC, SM624290021WC, SM623470001WC, SM623470002WC, SM623470003WC, SM623470004WC, SM623470005WC, SM623470006WC, SM623470007WC, SM623470008WC, SM623470009WC, SM623470010WC, SM623470011WC, SM623470012WC, SM624240017WC, SM624240013WC, SM624240014WC, SM624240015WC, SM624240016WC, SM624110001WC, SM624330022WC, SM624330023WC.

Other recalls by GE Medical Systems China Co., Ltd.

  • Z-0915-2026 Class I — GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field R (November 14, 2025)
  • Z-0914-2026 Class I — GE Healthcare Carestation anesthesia system, product number and REF numbers: (November 14, 2025)
  • Z-0913-2026 Class I — GE Healthcare Carestation anesthesia system, product number and REF numbers: (November 14, 2025)
  • Z-2030-2025 Class II — GE Healthcare Versana Ultrasound Systems, sold under the following names and Mod (May 16, 2025)
  • Z-2029-2025 Class II — GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagno (May 16, 2025)
  • Z-1628-2025 Class I — GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 (March 21, 2025)
  • Z-1629-2025 Class I — GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002 (March 21, 2025)
  • Z-1627-2025 Class I — GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200 (March 21, 2025)
  • Z-1637-2025 Class I — GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000 (March 21, 2025)
  • Z-1632-2025 Class I — GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 (March 21, 2025)