Medical device recalls Moderate risk

GE Healthcare, LLC recalls Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

Recall date
May 2, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2703-2017
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
US Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL GA, ID,IL, IN, KY, LA, , MA, MD, MI, MO, MS, MT, MN, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, and UT. OUS: Algeria Argentina Australia Austria Belgium Bolivia Bosnia and Herzegovina Brazil Bulgaria Cambodia Ca…

Why it was recalled

Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction

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

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