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U.S. Department of Health and Human Services

Class 2 Device Recall Barco MDRC1119 Front Cover Kit

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 Class 2 Device Recall Barco MDRC1119 Front Cover Kitsee related information
Date Initiated by FirmMarch 30, 2017
Create DateNovember 30, 2018
Recall Status1 Terminated 3 on May 04, 2020
Recall NumberZ-0527-2019
Recall Event ID 81239
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductOptional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
Code Information Part Numbers C9826108, C9826109, C9826096, C9826097
FEI Number 3004455125
Recalling Firm/
Manufacturer		 Barco N.V.
President Kennedypark 35
Kortrijk Belgium
For Additional Information ContactInge Govaerts
56-233211
Manufacturer Reason
for Recall		If metal strips are removed and re-applied to another display, there is potential for the metal strips to be deformed resulting in a smaller contact surface with the front cover magnet strips. There is a risk that the protective front cover could come loose and may fall down.
FDA Determined
Cause 2		Device Design
ActionCustomers were notified via email on about 03/30/2017. Customers were alerted that a safety related update has been made to the installation manual. A safety notice has been shipped to distributors with the updated installation instructions manual and an acknowledgement letter. Distributors were asked to do the following: a) Inform all your customers who have purchased the Front Cover Kit by sending them the Safety Notice; b) Send the updated installation instructions to all your customers who have purchased the Front Cover Kit; c) Fill out the acknowledgment letter; attach and send in reply to this email.
Quantity in Commerce2,087 units
DistributionWorldwide - US Nationwide Distribution to CA, IL, GA, TX, and WI. In the countries of Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Poland, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey.
Total Product Life CycleTPLC 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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