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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1625-2025

GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.

Publicado el 7 de mayo de 2025 · Inicio del retiro: 21 de marzo de 2025

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Medical Systems China Co., Ltd.
Distribuidor
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.
Lote
GTIN 00840682124546, Serial Numbers: SM623510024WB, SM623510028WB, SM623510029WB, SM623510030WB, SM623510031WB, SM623510032WB, SM623510025WB, SM623510026WB, SM623510027WB, SM624390041WB, SM624390042WB, SM623510033WB, SM623510034WB, SM624220006WB, SM624220008WB, SM623160001WB, SM623160002WB, SM624120009WB, SM624120010WB, SM624510014WB, SM624510015WB, SM624510016WB, SM624250055WB, SM624250056WB, SM624120013WB, SM624120015WB, SM624320001WB, SM623250007WB, SM623250011WB, SM624250057WB, SM624250058WB, SM624250059WB, SM624250060WB, SM624250061WB, SM624320002WB, SM624370013WB, SM624370014WB, SM624370015WB, SM624370016WB, SM624370017WB, SM624370018WB, SM623460225WB, SM623460226WB, SM623460227WB, SM623460228WB, SM623460229WB, SM623460230WB, SM623460231WB, SM624120007WB, SM624120008WB, SM623250005WB, SM623250006WB, SM623460223WB, SM623460224WB, SM623390147WB, SM624120011WB, SM624120012WB, SM624120014WB, SM623250001WB, SM623250002WB, SM623250003WB, SM623250004WB, SM623390148WB, SM623390149WB, SM623390150WB, SM623390151WB, SM623390152WB, SM624120001WB, SM624120002WB, SM624120003WB, SM624120004WB, SM624120005WB, SM624120006WB, SM624120016WB, SM624120017WB, SM624120018WB, SM623140001WB, SM623140002WB, SM623140003WB, SM623230040WB, SM623230041WB, SM623230042WB, SM623100004WB, SM623100005WB, SM623100006WB, SM623100007WB, SM623100008WB, SM623370090WB, SM623370092WB, SM623370094WB, SM623370095WB, SM623020002WB, SM623240002WB, SM623240003WB, SM623240004WB, SM623240005WB, SM623500007WB, SM623500008WB, SM623500009WB, SM623500010WB, SM623500011WB, SM623500012WB, SM623240007WB, SM623240008WB, SM623240009WB, SM623240010WB, SM623240011WB, SM623240012WB, SM623240013WB, SM623240014WB, SM623370091WB, SM623370093WB, SM623010006WB, SM623110011WB, SM623110012WB, SM623240006WB, SM623240001WB, SM624380007WB, SM624380008WB, SM624380009WB, SM624380010WB, SM624380011WB, SM623470244WB, SM623470245WB, SM623440188WB, SM623440189WB, SM623440190WB, SM623430161WB, SM623430162WB, SM623430163WB, SM623430164WB, SM623430165WB, SM624110040WB, SM624110041WB, SM624110042WB, SM624110043WB, SM624110044WB, SM624110045WB, SM624110046WB, SM623290015WB, SM623290016WB, SM623290017WB, SM624020001WB, SM624020002WB, SM624100029WB, SM624100030WB, SM624100031WB, SM624100032WB, SM624100033WB, SM623270009WB, SM623470248WB, SM623470249WB, SM623170001WB, SM623170002WB, SM623440191WB, SM624020003WB, SM624100034WB, SM624100035WB, SM624100036WB, SM624100037WB, SM624100038WB, SM624100039WB, SM624250043WB, SM624250044WB, SM624250045WB, SM624250046WB, SM624250047WB, SM624250048WB, SM624250049WB, SM624250050WB, SM624250051WB, SM624250052WB, SM624250053WB, SM624250054WB, SM624370019WB, SM624370020WB, SM624370021WB, SM624370022WB, SM624370023WB, SM624370024WB, SM624370025WB, SM624370026WB, SM624370027WB, SM623150008WB, SM623470247WB, SM623290001WB, SM624020004WB, SM623290013WB, SM623130001WB, SM625020001WB, SM625020002WB, SM623270004WB, SM623270005WB, SM623270006WB, SM623270007WB, SM623270008WB, SM623290014WB, SM623470246WB, SM623260032WB, SM623260033WB, SM623070005WB, SM624010001WB, SM624160001WB, SM624160002WB, SM624160003WB, SM624160004WB, SM624160005WB, SM624270001WB, SM624270002WB, SM624340002WB, SM624340003WB, SM623130002WB, SM623130003WB, SM623430180WB, SM623430181WB, SM624170001WB, SM624340004WB, SM624340005WB, SM624340006WB, SM624340007WB, SM624340008WB, SM624340009WB, SM623430168WB, SM623430169WB, SM623430170WB, SM623430171WB, SM623430172WB, SM623430173WB, SM623290019WB, SM623290020WB, SM624050009WB, SM624110062WB, SM624110063WB, SM623400153WB, SM624240001WB, SM623270001WB, SM624270003WB, SM623490007WB, SM623180001WB, SM623180002WB, SM623180003WB, SM623180004WB, SM623360046WB, SM623360048WB, SM623360049WB, SM623360053WB, SM624120029WB, SM623020001WB, SM623090027WB, SM623090028WB, SM623460214WB, SM623360044WB, SM623360047WB, SM623360050WB, SM623360051WB, SM623360057WB, SM623360058WB, SM623470251WB, SM623470252WB, SM623470253WB, SM623470254WB, SM623470255WB, SM623470256WB, SM624110014WB, SM
Clasificación de riesgo
Class I
Área (FDA)
device
País
China

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