Medical device recalls Moderate risk

Barco N.V. recalls Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional ki…

Recall date
March 30, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0527-2019
FDA classification
Class II
Brand / firm
Barco N.V.
Sold / distributed
Worldwide - US Nationwide Distribution to CA, IL, GA, TX, and WI. In the countries of Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Poland, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey.

Why it was recalled

If metal strips are removed and re-applied to another display, there is potential for the metal strips to be deformed resulting in a smaller contact surface with the front cover magnet strips. There is a risk that the protective front cover could come loose and may fall down.

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

What was recalled

Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).

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