Recall Z-0692-2018— Stryker Communications

Name: FDA recall Z-0692-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-26

Class II · Terminated

Class II FDA medical device recall by Stryker Communications, initiated 2018-01-26, terminated 2019-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.. Reason: The mounts on the monitor may have an insufficient (missing or incomplete) weld..

Recalling firm: Stryker Communications
Classification: Class II
Status: Terminated
Initiated: 2018-01-26
Terminated: 2019-03-19
Firm location: Flower Mound, TX, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.