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Recall Observatory FDA recall evidence

Device product

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

Z-1626-2025

March 21, 2025

Class I

Product summary

Firm
GE Medical Systems China Co., Ltd.
Event
Event 96634
Status
Ongoing
Classification
Class I
Quantity
27 units
Official record key
device-enforcement:Z-1626-2025

Official wording

Reason: 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.

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.