Recall Z-0527-2019
Barco N.V. · initiated March 30, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
Codes / lots: Part Numbers C9826108, C9826109, C9826096, C9826097
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: Device Design
Action taken
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 reply to this email.
Details
- Recall number
- Z-0527-2019
- Initiated
- March 30, 2017
- Terminated
- May 4, 2020
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- 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.
- Recalling firm
- Barco N.V., Kortrijk