GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000
FDA Recall #Z-1637-2025 — Class I — March 21, 2025
Product Description
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000
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.
Recalling Firm
GE Medical Systems China Co., Ltd. — Wuxi, N/A
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
74 units
Distribution
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 00840682146425, Serial Numbers: SQT23330001WA, SQT23080006WA, SQT23080007WA, SQT23080008WA, SQT23080009WA, SQT23080010WA, SQT23080011WA, SQT24440011WA, SQT23150001WA, SQT23070001WA, SQT23070002WA, SQT24430006WA, SQT23200001WA, SQT23200002WA, SQT23200003WA, SQT23200004WA, SQT23200005WA, SQT24290003WA, SQT24510015WA, SQT24520016WA, SQT23360008WA, SQT23360002WA, SQT23360003WA, SQT23360004WA, SQT23360005WA, SQT23360006WA, SQT23360007WA, SQT23170001WA, SQT24430007WA, SQT24430008WA, SQT24430009WA, SQT24430010WA, SQT23190004WA, SQT24410005WA, SQT23050001WA, SQT23050002WA, SQT23050003WA, SQT23050004WA, SQT23060001WA, SQT23060002WA, SQT23060003WA, SQT23300002WA, SQT24230002WA, SQT24440012WA, SQT24440013WA, SQT24440014WA, SQT23400001WA, SQT23400002WA, SQT24022000WA, SQT23480001WA, SQT23370002WA, SQT23370007WA, SQT23370004WA, SQT23370006WA, SQT23370005WA, SQT23370001WA, SQT23370003WA, SQT23370008WA, SQT23370009WA, SQT23370010WA, SQT23370011WA, SQT23460001WA, SQT24160001WA, SQT23350001WA, SQT23420001WA, SQT23420002WA, SQT23190001WA, SQT23190002WA, SQT23190003WA, SQT23190005WA, SQT23190006WA, SQT23190007WA, SQT23190008WA, SQT23190009WA.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.