Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Display

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Surgical Displaysee related information
Date Initiated by FirmSeptember 09, 2008
Date PostedNovember 07, 2008
Recall Status1 Terminated 3 on June 02, 2009
Recall NumberZ-0276-2009
Recall Event ID 50068
Product Classification Digital Display Monitor - Product Code RHF
ProductBarco 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
FEI Number 3004455125
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
ActionConsignees 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 Commerce25 units
DistributionNationwide Distribution --- including states of AK, GA, IL, and MA.
Total Product Life CycleTPLC 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.
-
-