Z-0227-2016 Class II Terminated
FDA device recall Z-0227-2016 was initiated by Barco Inc. on May 28, 2015 and is designated Class II. Reason for recall: User settings were no longer on the monitor's memory after these systems were powered off and back on. The recall status is terminated (terminated March 9, 2017). Affected quantity: 462 devices in US.
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2015
- Initiation Date
- May 28, 2015
- Termination Date
- March 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 462 devices in US
Product Description
Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
Reason for Recall
User settings were no longer on the monitor's memory after these systems were powered off and back on.
Distribution Pattern
US Distribution to the states of : AZ, CA, FL, GA, IL, MA, NE, NJ, OH, OR and TX., and Internationally to Canada.
Code Information
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