GE Medical Systems China Co., Ltd. recalls Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

Recall date

October 11, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0579-2018

FDA classification

Class II

Brand / firm

GE Medical Systems China Co., Ltd.

Sold / distributed

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, Bolivi…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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