Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0276-2009

Barco Surgical Display, Model MDSC-2124 The 24-inch MDSC-2124 is a near-patient surgical display that uses...

Barco N.V. / initiated 2008-09-09 / Terminated

Barcoview began a recall of Barco Surgical Display, Model MDSC-2124 The 24-inch MDSC-2124 is a near-patient surgical display that uses widescreen (16:10) LCD technology featuring full... on . The reason FDA records is "The front protective cover may loosen and completely fall off". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0276-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Barco N.V.
Product
Barco Surgical Display, Model MDSC-2124 The 24-inch MDSC-2124 is a near-patient surgical display that uses widescreen (16:10) LCD technology featuring full High Definition resolution (1920 x 1200). Featuring broad input connectivity, the MDSC-2124 offers a versatile display solution for HD endoscopy cameras, room and boom cameras, ultrasound, PACS and patient information.
Product code
RHF Digital Display Monitor
Reason for recall
The front protective cover may loosen and completely fall off.
FDA root cause
Other
Action
Consignees were notified via a Field Safety Notice letter on 09/09/2008. They were instructed to inspect the units to check if the front panel is tightly secured to the display housing. Any front panel found to be lose or showing a gap between the front plate and the back shell of the monitor is to be reported the BARCO Service & Support organization and is to be secured using adhesive tape. Follow up Field Safety Notice was sent to consignees on 09/26/2008 indicating the root cause and the firm's corrective field actions implemented October 15, 2008.
Quantity in commerce
25 units
Distribution
Nationwide Distribution --- including states of AK, GA, IL, and MA.
Product codes and lots
All lots