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
January 26, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0692-2018
FDA classification
Class II
Brand / firm
Stryker Communications
Sold / distributed
Distribution was made to medical facilities nationwide, including government and military distribution. Foreign distribution was made to Canada, Belgium, China, United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia.

Why it was recalled

The mounts on the monitor may have an insufficient (missing or incomplete) 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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