Medical device recalls Moderate risk

Stryker Communications recalls Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted…

Recall date
August 1, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2446-2019
FDA classification
Class II
Brand / firm
Stryker Communications
Sold / distributed
Distribution was made to CA, CO, CT, FL, GA, IL, IN, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, SC, TN, TX, and WI. There was foreign distribution to Canada and Germany. There was no government/military distribution.

Why it was recalled

The mounts on the monitor may have an insufficient weld.

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

What was recalled

Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.

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