Events

Recall of Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems China Co., Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78469
  • Event Risk Class
    Class 2
  • Event Number
    Z-0579-2018
  • Event Initiated Date
    2017-10-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159630
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Gas-machine, anesthesia - Product Code BSZ
  • Reason
    Possible incomplete seal between the co2 absorber and the breathing circuit co2 bypass port assembly of the carestation 600 series systems.
  • Action
    On approximately 10/11/2017 customers were notified of the recall via letter. Instructions include that if elevated FiCO2 is observed, to increase the flow of fresh gas to reduce the volume of patient gas that is rebreathed. If the FiCO2 cannot be adequately reduced with this action, consider switching to another anesthesia delivery device. GE Healthcare is planning to release revised parts that minimize the likelihood of incomplete gas flow through the CO2 absorbent canister. GE Healthcare will correct all affected devices by installing updated parts at no cost to the customer. The updated parts will be included in the 12-month preventative maintenance schedule for the Carestation 600 Series System.

Device

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV. Distributed internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote Di'Viore, Croatia, Czech Republic, Democratic Republic of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mauritius, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zimbabwe.
  • Product Description
    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
  • Manufacturer
    GE Medical Systems China Co., Ltd.

Manufacturer

GE Medical Systems China Co., Ltd.
  • Manufacturer Address
    GE Medical Systems China Co., Ltd., National Hi-Tech Dev. Zone, NO. 19 Changjiang Road, Wuxi China
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA