Z-1627-2025 Class I Ongoing
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
- 383 units
Product Description
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
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.
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 00195278439536, Serial Numbers: SM624510015MD, SM624510016MD, SM624510017MD, SM624510018MD, SM624450001WD, SM624450002WD, SM624450003WD, SM624450004WD, SM624450005WD, SM624450006WD, SM624450007WD, SM624450008WD, SM624450009WD, SM624450010WD, SM623290016WD, SM623290017WD, SM624470034WD, SM624470035WD, SM624470036WD, SM624470037WD, SM624470038WD, SM624470039WD, SM624470040WD, SM624470041WD, SM624470042WD, SM624470043WD, SM624280008WD, SM624320001WD, SM624320002WD, SM624320003WD, SM624320004WD, SM624320005WD, SM624320006WD, SM624280005WD, SM624280006WD, SM624280007WD, SM624320007WD, SM624320008WD, SM624320009WD, SM624320010WD, SM624320011WD, SM624320012WD, SM624320013WD, SM623290012WD, SM623290015WD, SM623290013WD, SM623290014WD, SM623290018WD, SM623290019WD, SM624370001WD, SM624470002MD, SM624470003MD, SM624470004MD, SM624470005MD, SM624470006MD, SM624340001MD, SM624340002MD, SM624340003MD, SM624340011WD, SM624340012WD, SM624340013WD, SM624340014WD, SM624340015WD, SM624440001MD, SM624440002MD, SM624500046WD, SM624500047WD, SM624500048WD, SM625020019MD, SM624370002WD, SM624370003WD, SM624500049WD, SM624520051WD, SM624520052WD, SM624520053WD, SM624520054WD, SM625020069WD, SM625030078WD, SM624450011WD, SM624450012WD, SM624450014WD, SM624450015WD, SM624450013WD, SM625030082WD, SM624400006MD, SM624400007MD, SM624400008MD, SM624400009MD, SM624400010MD, SM624400011MD, SM624400012MD, SM624220002WD, SM624330002WD, SM624290006WD, SM624290007WD, SM624470033WD, SM624280001WD, SM624280002WD, SM624280003WD, SM625010055WD, SM624270002WD, SM624330001WD, SM624190009WD, SM624220001WD, SM624460002WD, SM624460018WD, SM624460020WD, SM624460014WD, SM624280004WD, SM624340016WD, SM624340017WD, SM624370004WD, SM624370005WD, SM624340020WD, SM624340026WD, SM624320014WD, SM624290018WD, SM624460019WD, SM624500050WD, SM724280001WD, SM724280002WD, SM724320015WD, SM724330009WD, SM724320044WD, SM724290003WD, SM624290021WD, SM624170010WD, SM624290010WD, SM624460004WD, SM624460005WD, SM624170001WD, SM624350002WD, SM624290001WD, SM624290002WD, SM624290003WD, SM624290004WD, SM624340010WD, SM624170012WD, SM624290015WD, SM624340027WD, SM624190003WD, SM624190004WD, SM624190005WD, SM624190006WD, SM624370006WD, SM624390002WD, SM624390003WD, SM624460016WD, SM624290019WD, SM624460003WD, SM624340018WD, SM624470027WD, SM624290011WD, SM624340021WD, SM624370007WD, SM624340022WD, SM624170002WD, SM724320046WD, SM724320047WD, SM624170011WD, SM624340009WD, SM624450019WD, SM624170009WD, SM624210007WD, SM624290017WD, SM624450016WD, SM724320040WD, SM624190002WD, SM624210006WD, SM624210005WD, SM624370008WD, SM624480044WD, SM724340001WD, SM724340002WD, SM624290009WD, SM624390001WD, SM624340003WD, SM624340004WD, SM624340005WD, SM624340006WD, SM624340007WD, SM624170005WD, SM624170003WD, SM624470029WD, SM624470030WD, SM624470031WD, SM624340028WD, SM624290005WD, SM624290013WD, SM624290014WD, SM624290020WD, SM625020060WD, SM624290008WD, SM624410005WD, SM624340019WD, SM624210003WD, SM624450020WD, SM624340001WD, SM624340002WD, SM624450018WD, SM624210004WD, SM624290022WD, SM624470026WD, SM625020059WD, SM624210001WD, SM624340025WD, SM624460015WD, SM624290012WD, SM624210002WD, SM724320031WD, SM624460001WD, SM624190007WD, SM624190008WD, SM624170006WD, SM624170007WD, SM624170008WD, SM624460024WD, SM624290016WD, SM624470009MD, SM624470010MD, SM624470011MD, SM624460022WD, SM624460008WD, SM624460009WD, SM624460010WD, SM624460023WD, SM624460011WD, SM624340029WD, SM624460007WD, SM624410003WD, SM624410004WD, SM624340030WD, SM625010056WD, SM625020063WD, SM625020064WD, SM625020065WD, SM624460013WD, SM625020061WD, SM625020057WD, SM624460012WD, SM624470032WD, SM624410001WD, SM624410002WD, SM624330035MD, SM624330036MD, SM624330037MD, SM624330008MD, SM624330011MD, SM624330012MD, SM624330013MD, SM624330014MD, SM624330032MD, SM623300001MD, SM623300002MD, SM623300008MD, SM624330017MD, SM624330027MD, SM624330039MD, SM624330005MD, SM624330006MD, SM624330007MD, SM624330009MD, SM624330015MD, SM624330030MD, SM624430001MD, SM624430002MD, SM624430003MD, SM624430004MD, SM624430005MD, SM624430006MD, SM624430007MD, SM624430008MD, SM624430009MD, SM624430010MD, SM624430011MD, SM624430012MD, SM624440003MD, SM624440005MD, SM624440006MD, SM624440007MD, SM624440008MD, SM624440010MD, SM624440011MD, SM624440012MD, SM624440013MD, SM624440014MD, SM624440015MD, SM624440016MD, SM624440004MD, SM624440009MD, SM625030087WD, SM625070100WD, SM624330018MD, SM624330028MD, SM624330026MD, SM624330029MD, SM624330025MD, SM624330019MD, SM624330020MD, SM624330021MD, SM624330022MD, SM624330024MD, SM624330031MD, SM624330034MD, SM624330033MD, SM624330001MD, SM624330002MD, SM624330004MD, SM624330023MD, SM623300003MD, SM623300007MD, SM623300009MD, SM624330010MD, SM624330038MD, SM624330003MD, SM624330016MD, SM624500013MD, SM624500014MD, SM624240001WD, SM624230001WD, SM624460006WD, SM624360001WD, SM624270001WD, SM624340008WD, SM625030081WD, SM625040092WD, SM624270003WD, SM624180001MD, SM624180002MD, SM624180003MD, SM624180004MD, SM624180005MD, SM624180006MD, SM624180007MD, SM624180008MD, SM624180009MD, SM624180010MD, SM625030088WD, SM625030089WD, SM625030090WD, SM624460021WD, SM624410002MD, SM624410004MD, SM624470007MD, SM624470008MD, SM625030027MD, SM625030028MD, SM625030029MD, SM625030030MD, SM625030032MD, SM625030034MD, SM625050038MD, SM625050039MD, SM625050040MD, SM625050041MD, SM625050042MD, SM624390006MD, SM625030031MD, SM624390004MD, SM624390005MD, SM624390007MD, SM625030033MD, SM624390001MD, SM624400004MD, SM624400005MD, SM624400003MD, SM624390002MD, SM624390003MD, SM624400002MD, SM624400020MD, SM624410003MD, SM624410005MD, SM624410001MD, SM625030083WD, SM625030084WD, SM625030085WD, SM625030086WD, SM625030020MD, SM625040035MD, SM625040036MD, SM625040037MD, SM625060060MD, SM624320004MD.