GE Healthcare CARESTATION 650C A2 recall
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
Why was GE Healthcare CARESTATION 650C A2 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00840682124539, Serial Numbers: SM823250002WB, SM823250003WB, SM824100001WB, SM824100002WB, SM823080001WB, SM823080002WB, SM823250001WB, SM824380004WB, SM823140001WB, SM824410006WB, SM824410007WB, SM824410008WB, SM824380005WB, SM823460001WB, SM823460002WB.
- Product
- GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
- Recalling firm
- GE Medical Systems China Co., Ltd.
- Quantity
- 15 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.
- Recall date
- May 7, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)