Medical device recalls Moderate risk

GE Healthcare, LLC recalls ADVANTX LCV+

Recall date
November 21, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0908-2017
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hunga…

Why it was recalled

GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 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

ADVANTX LCV+

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