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 LCD Display Monitor

  • 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 LCD Display Monitor see related information
Date Initiated by Firm May 28, 2015
Date Posted November 05, 2015
Recall Status1 Terminated 3 on March 09, 2017
Recall Number Z-0227-2016
Recall Event ID 72390
Product Classification Camera, surgical and accessories - Product Code KQM
Product Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
Code Information Model MDSC-2224 (24 inch) with part numbers - K9307916 - 991932387121, K9307919 - 991932387131, K9307912 - 991932387071, K9307913 - 991932387081; Model MDSC-2226 (26 inch) with part numbers - K9307906 - 991932387011, K9307907 - 991932387031, K9307908 - 991932387021, 991932387041, 991932387061, 991932387111, 991932387141, 991932389071, 991932389081, 991932389091; Model MDSC-2242 (42 inch) with part numbers - K9307914 - 991932387091, K9307915 - 991932387101
Recalling Firm/
Manufacturer		 Barco Inc.
3059 Premiere Pkwy
Duluth GA 30097-4905
For Additional Information Contact Toni Lynn Hauck
678-475-8156
Manufacturer Reason
for Recall		 User settings were no longer on the monitor's memory after these systems were powered off and back on.
FDA Determined
Cause 2		 Process design
Action Barco sent an "Urgent Medical Device Correction Notice" dated May 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notice contained "Interim Corrective Action" and information about a "Final Corrective Action". The notice included a reply notice to be sent back to Barco and also requested a sub-recall. For further questions, please call (678) 475-8156.
Quantity in Commerce 462 devices in US
Distribution US Distribution to the states of : AZ, CA, FL, GA, IL, MA, NE, NJ, OH, OR and TX., and Internationally to Canada.
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.
-
-