Z-0227-2016Class II

Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42...

Name: Z-0227-2016 Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42...
Creator: Barco Inc.
Published: 2015-05-28
License: https://open.fda.gov/license/

Barco, Inc / initiated 2015-05-28 / Terminated / root cause: manufacturing process

FDA source

Barco Inc. began a recall of Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch) on 2015-05-28. FDA classified it as Class II and gives the reason as "User settings were no longer on the monitor's memory after these systems were powered off and back on". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0227-2016
Classification: Class II
Status: Terminated
Initiated: 2015-05-28
Posted: 2015-11-05
Terminated: 2017-03-09
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)
Product code: KQM Camera, Surgical And Accessories
Reason for recall: User settings were no longer on the monitor's memory after these systems were powered off and back on.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0227-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0227-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-05

Product code KQM

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)