GE Medical Systems China Co., Ltd.: Medical Device Recall in 2025 - (Recall #: Z-1636-2025)

GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002

Class I

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.

GTIN 00840682146470, Serial Numbers: SQS23480001WB, SQS23480002WB, SQS23480003WB, SQS23480004WB, SQS23480005WB, SQS23500002WB, SQS24510072WB, SQS24510073WB, SQS24510074WB, SQS24510075WB, SQS24510076WB, SQS24250017WB, SQS24250018WB, SQS24250019WB, SQS24370029WB, SQS24370030WB, SQS24370031WB, SQS23510004WB, SQS23370007WB, SQS23370008WB, SQS23370009WB, SQS23370010WB, SQS23370011WB, SQS23370012WB, SQS23370013WB, SQS23370014WB, SQS23370015WB, SQS23370016WB, SQS23370017WB, SQS23370018WB, SQS23510005WB, SQS23510006WB, SQS23510007WB, SQS23510008WB, SQS23510009WB, SQS23510010WB, SQS23510011WB, SQS24110012WB, SQS24110013WB, SQS24110014WB, SQS24110015WB, SQS24110016WB, SQS24110017WB, SQS24250014WB, SQS24250015WB, SQS24250016WB, SQS24120023WB, SQS24120024WB, SQS24120025WB, SQS24120026WB, SQS24120027WB, SQS24120028WB, SQS23250006WB, SQS23470001WB, SQS23470002WB, SQS23280001WB, SQS23280002WB, SQS24110001WB, SQS24510063WB, SQS24510064WB, SQS24510065WB, SQS23520005WB, SQS23250002WB, SQS23250003WB, SQS23250004WB, SQS23090001WB, SQS23090002WB, SQS24510079WB, SQS24510080WB, SQS24510081WB, SQS24510082WB, SQS24510083WB, SQS24510084WB, SQS24510085WB, SQS24510086WB, SQS24510087WB, SQS24510088WB, SQS23250001WB, SQS23490003WB, SQS23350001WB, SQS23350002WB, SQS23120001WB, SQS23510016WB, SQS23510017WB, SQS23510018WB, SQS23510019WB, SQS23510020WB, SQS23510021WB, SQS23510022WB, SQS23510023WB, SQS23510024WB, SQS24110003WB, SQS24110004WB, SQS24110005WB, SQS24110020WB, SQS24110021WB, SQS24110022WB, SQS23510012WB, SQS23510013WB, SQS23510014WB, SQS23510015WB, SQS24370032WB, SQS24370033WB, SQS24370034WB, SQS24370035WB, SQS24370036WB, SQS24370037WB, SQS24370038WB, SQS24370039WB, SQS24370040WB, SQS24370041WB, SQS23520001WB, SQS23520002WB, SQS23520003WB, SQS23520004WB, SQS23510003WB, SQS23370019WB, SQS23370025WB, SQS23510002WB, SQS24510069WB, SQS24510070WB, SQS24510071WB, SQS24480060WB, SQS24480061WB, SQS24370027WB, SQS23500001WB, SQS23500003WB, SQS23500005WB, SQS23500006WB, SQS23500007WB, SQS23500008WB, SQS23500004WB, SQS24380042WB, SQS24380043WB, SQS24080001WB, SQS24120002WB, SQS25040093WB, SQS24510066WB, SQS24510067WB, SQS24510068WB, SQS23500009WB, SQS24230012WB, SQS23210001WB, SQS23380026WB, SQS23380027WB, SQS23380028WB, SQS24120003WB, SQS24120004WB, SQS24120005WB, SQS24460048WB, SQS24460049WB, SQS24460050WB, SQS24460051WB, SQS24460052WB, SQS24460053WB, SQS24460054WB, SQS24460055WB, SQS24460056WB, SQS24490062WB, SQS23100001WB, SQS23310001WB, SQS23310002WB, SQS24330020WB, SQS24330021WB, SQS24330022WB, SQS24330023WB, SQS24110002WB, SQS24250013WB, SQS24470059WB, SQS24210006WB, SQS24110006WB, SQS24110007WB, SQS24110008WB, SQS24110009WB, SQS24110010WB, SQS24110011WB, SQS24110019WB, SQS24360026WB, SQS23460030WB, SQS23460031WB, SQS24110018WB, SQS24470057WB, SQS24470058WB, SQS23360003WB, SQS23360004WB, SQS23360005WB, SQS23490002WB, SQS24120001WB, SQS23080001WB, SQS23080002WB, SQS23080003WB, SQS23080004WB, SQS23080005WB, SQS23080006WB, SQS23170001WB, SQS23250005WB, SQS24210007WB, SQS24210008WB, SQS23380029WB, SQS24510077WB, SQS24510078WB, SQS23480006WB, SQS23480007WB, SQS24450047WB, SQS24220009WB, SQS24220010WB, SQS24220011WB, SQS23240001WB, SQS23240002WB, SQS23240003WB, SQS23360006WB, SQS24520089WB, SQS24520090WB, SQS23490001WB, SQS24090001WB, SQS24090002WB, SQS24090003WB.

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.

Voluntary: Firm initiated