Recall Z-0527-2019 ยท OWB Interventional Fluoroscopic X-Ray System
Barco N.V.
Optional 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).
| Date | Mar 30, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Customers 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 repl |
| Quantity | 2,087 units |
| Distribution | Worldwide - 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.