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Terminated

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

FDA Recall Z-0227-2016 · Posted 2015-11-05

Recalling FirmBarco Inc.
Recall StatusTerminated
Product CodeKQM
Date Initiated2015-05-28
Date Terminated2017-03-09
Product Quantity462 devices in US

Reason for Recall

User settings were no longer on the monitor's memory after these systems were powered off and back on.

Firm 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.

Root Cause

Process design

Distribution Pattern

US Distribution to the states of : AZ, CA, FL, GA, IL, MA, NE, NJ, OH, OR and TX., and Internationally to Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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