Home / Recalls / GE Medical Systems China Co., Ltd. / Z-1632-2025

Z-1632-2025 Class I Ongoing

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

FDA device recall Z-1632-2025 was initiated by GE Medical Systems China Co., Ltd. on March 21, 2025 and is designated Class I. Reason for recall: 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 b… The recall status is ongoing. Affected quantity: 69 units.

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: 69 units

Product Description

GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.

Reason for Recall

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 00840682103954, Serial Numbers: SM823080001MA, SM823080002MA, SM823080003MA, SM823080004MA, SM824210002WA, SM824210003WA, SM824210004WA, SM824230005WA, SM824230006WA, SM823440005WA, SM823440006WA, SM823440007WA, SM823440008WA, SM823050001WA, SM823050002WA, SM823050003WA, SM823050004WA, SM823050005WA, SM823060001WA, SM823060002WA, SM824030001MA, SM824030002MA, SM824030003MA, SM824030004MA, SM824030005MA, SM824030006MA, SM824030007MA, SM824030008MA, SM824030009MA, SM824030010MA, SM823120001MA, SM824320007WA, SM823010001WA, SM823430004WA, SM824050003MA, SM824050004MA, SM824050005MA, SM824050006MA, SM824050007MA, SM824050001WA, SM824050002WA, SM823230001MA, SM823230002MA, SM824040001WA, SM824450010WA, SM823410001WA, SM823410002WA, SM823420003WA, SM823480001WA, SM823170001MA, SM823170002MA, SM823170003MA, SM823170004MA, SM823170005MA, SM823170006MA, SM823280001MA, SM823280002MA, SM823280003MA, SM824430009WA, SM823370001MA, SM823370002MA, SM824410006MA, SM824410007MA, SM824410008MA, SM824440009MA, SM824440010MA, SM824440011MA, SM824440012MA, SM824440013MA.

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