FDA Medical devices recall · May 7, 2025

GE Healthcare CARESTATION 620 A2, Model recall

This is an FDA Class I recall — the most serious type.

Read the official FDA notice ↗

Product

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

Why was it 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 you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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, SM623500

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.

States: Puerto Rico

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-1625-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.