Z-1636-2025 Class I Ongoing

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

FDA device recall Z-1636-2025 was initiated by GE Medical Systems China Co., Ltd. on Mar 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… The recall status is ongoing. Affected quantity: 217 units.

Recall details

Product Type
Devices
Report Date
May 7, 2025
Initiation Date
Mar 21, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
217 units

Product description

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1636-2025
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for Z-1636-2025. Report a data issue: hello@regdatalab.com.