FDA recall Z-0579-2018

GE Medical Systems China Co., Ltd. · Class II · device

Product

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

Reason for recall

Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.

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, S

Key facts

Status
Ongoing
Initiation date
2017-10-11
Report date
2018-02-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wuxi, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0579-2018