Class 2 Device Recall Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel

• Date Initiated by Firm: January 26, 2018
• Create Date: February 23, 2018
• Recall Status: Terminated on March 19, 2019
• Recall Number: Z-0692-2018
• Recall Event ID: 79116
• Product Classification: Light, surgical, ceiling mounted - Product Code FSY
• Product: Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
• Code Information: United States and Canada: Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230; International: Serial numbers 6145060-O11628 to 6176090-V14102
• FEI Number: 3002975342
• Recalling Firm/ Manufacturer: Stryker Communications; 571 Silveron Blvd; Flower Mound TX 75028
• For Additional Information Contact: Nicole L. Kubat; 469-470-4318
• Manufacturer Reason for Recall: The mounts on the monitor may have an insufficient (missing or incomplete) weld.
• FDA Determined Cause: Process control
• Action: The recalling firm issued letters dated 1/26/2018 via FedEx on 1/26/2018 explaining the issue and the potential adverse consequences.
• Quantity in Commerce: 850
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.