Recall Z-0227-2016 ยท KQM Camera, Surgical And Accessories
Barco Inc.
Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
| Date | Nov 5, 2015 (initiated May 28, 2015) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.