Z-0527-2019Class II

Optional MDRC-1119 Front Cover Attachment Kit for review display monitors

Name: Z-0527-2019 Optional MDRC-1119 Front Cover Attachment Kit for review display monitors
Creator: Barco N.V.
Published: 2017-03-30
License: https://open.fda.gov/license/

Barco N.V. / initiated 2017-03-30 / Terminated / root cause: design

FDA source

Barco N.V. began a recall of 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... on 2017-03-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0527-2019
Classification: Class II
Status: Terminated
Initiated: 2017-03-30
Posted: 2018-11-30
Terminated: 2020-05-04
Recalling firm: Barco N.V.
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).
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA 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 reply to this email.
Quantity in commerce: 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.
Product codes and lots: Part Numbers C9826108, C9826109, C9826096, C9826097

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0527-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0527-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30

Product code OWB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)