FDA-Device2018-03-07Class II
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Stryker Communications
Hazard
The mounts on the monitor may have an insufficient (missing or incomplete) weld.
Sold states
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.
Affected count
850
Manufactured in
571 Silveron Blvd, N/A, Flower Mound, TX, United States
Products
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0692-2018Don't want to check this manually?
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