Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Barco

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Barco see related information
Date Initiated by Firm July 27, 2022
Date Posted September 29, 2022
Recall Status1 Open3, Classified
Recall Number Z-1854-2022
Recall Event ID 90807
510(K)Number K173381  
Product Classification Display, cathode-ray tube, medical - Product Code DXJ
Product Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Code Information a) K9303078A, UDI 05415334000056, all serial numbers; b) K9303097A, UDI 05415334001657, all serial numbers
Recalling Firm/
Manufacturer		 BARCO NV
Beneluxpark 8500
Kortrijk Bulgaria
Manufacturer Reason
for Recall		 installation issues
FDA Determined
Cause 2		 Labeling design
Action Barco NV began notifying its consignees on about August 29, 2022, via email, about the device malfunction and stated that they would be providing an updated instructions for use (IFU). The firm followed with a Field Safety Action, via email on the same day, which described the issue, potential risks and a copy of the updated IFU. The letter requested the following: 1. Fill out and send back Response Form 1 to Barco Key Account Manager after receipt of this Notice. 2. Read the updated installation instructions, including the potential risk of wrong installation. 3. Inform relevant partners and ask them to evaluate if their installations must be adapted. 4. Fill out and send back Response Form 2 to Barco Key Account Manager after completion of the actions.
Quantity in Commerce 169 devices
Distribution US Nationwide distribution in the states of FL, IL, NJ.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXJ and Original Applicant = Barco n.v.
-
-