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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel see related information
Date Initiated by Firm January 26, 2018
Create Date February 23, 2018
Recall Status1 Terminated 3 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
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 2		 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.
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