CLASS II Device recall · Reported 12 Dec 2018 · FDA Enforcement Report
Optional Mdrc-1119 Front Cover Attachment Kit recalled by Barco N.V
Barco N.V is recalling Optional Mdrc-1119 Front Cover Attachment Kit for review display monitors, distributed nationwide in the US. The recall was initiated on 30 Mar 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0527-2019
- FDA event ID
- 81239
- Recalling firm
- Barco N.V, Kortrijk, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Mar 2017
- FDA classified
- 30 Nov 2018
- Reported
- 12 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Patient Monitors
Timeline
| 30 Mar 2017 | Recall initiated by company | |
| 30 Nov 2018 | Classified by FDA | +610 days |
| 12 Dec 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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).
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Part Numbers C9826108, C9826109, C9826096, C9826097
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Barco N.V
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|---|---|---|---|---|---|
| Device | CLASS II | Model: Description/REF: Mna-420: Mna-420 ENC -H/K9303320 recalled | Barco N.V | Other | Nationwide |
| Device | CLASS II | Mna-420 Enc Hdmi, Material Number K9303311 recalled by Barco N.V | Barco N.V | Other | FL |
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