FDA Medical Device Recalls (openFDA)
Barco Inc.: Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
- Recall number
- Z-0227-2016
- Recalling firm
- Barco Inc.
- Product
- Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
- Status
- Terminated
- Initiated
- 2015-05-28
- Posted
- 2015-11-05
- Terminated
- 2017-03-09
- Reason
- User settings were no longer on the monitor's memory after these systems were powered off and back on.
- Root cause
- Process design
- Action
- Barco sent an "Urgent Medical Device Correction Notice" dated May 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notice contained "Interim Corrective Action" and information about a "Final Corrective Action". The notice included a reply notice to be sent back to Barco and also requested a sub-recall. For further questions, please call (678) 475-8156.
- Quantity
- 462 devices in US
- Distribution
- US Distribution to the states of : AZ, CA, FL, GA, IL, MA, NE, NJ, OH, OR and TX., and Internationally to Canada.
- Lot, serial or model codes
- Model MDSC-2224 (24 inch) with part numbers - K9307916 - 991932387121, K9307919 - 991932387131, K9307912 - 991932387071, K9307913 - 991932387081; Model MDSC-2226 (26 inch) with part numbers - K9307906 - 991932387011, K9307907 - 991932387031, K9307908 - 991932387021, 991932387041, 991932387061, 991932387111, 991932387141, 991932389071, 991932389081, 991932389091; Model MDSC-2242 (42 inch) with part numbers - K9307914 - 991932387091, K9307915 - 991932387101
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KQM
- Firm FEI
- 3004578804
- Firm city
- Duluth
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28