GE Medical Systems, LLC recalls GE Healthcare, Aisys Carestation.

Recall date

February 17, 2016

Source

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

Recall number

Z-1382-2016

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPU…

Why it was recalled

GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.

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

What was recalled

GE Healthcare, Aisys Carestation.