Medical device recalls Moderate risk

GE Healthcare, LLC recalls Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance…

Recall date
March 29, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1755-2019
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France,…

Why it was recalled

There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

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

What was recalled

Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.

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