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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Display

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  Class 2 Device Recall Surgical Display see related information
Date Initiated by Firm September 09, 2008
Date Posted November 07, 2008
Recall Status1 Terminated 3 on June 02, 2009
Recall Number Z-0276-2009
Recall Event ID 50068
Product Classification Digital Display Monitor - Product Code RHF
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.
Code Information All lots
Recalling Firm/
Manufacturer		 Barcoview
35 President Kennedy Park
Kortrijk Belgium
For Additional Information Contact
3256233 Ext. 459
Manufacturer Reason
for Recall		 The front protective cover may loosen and completely fall off.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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