Medical device recalls Moderate risk

GE Healthcare, LLC recalls Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote contro…

Recall date
March 29, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1751-2019
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

Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.

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