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 Olympus 4K UHD LCD Monitor

  • 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 Olympus 4K UHD LCD Monitorsee related information
Date Initiated by FirmJuly 07, 2026
Date PostedJuly 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2761-2026
Recall Event ID 99288
510(K)NumberK220069 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductOlympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
Code Information Model Number: OEV321UH. UDI-DI: 04953170418723. Serial Numbers: 7503474, 7503477, 7503479, 7503263, 7503264, 7503262, 7503261, 7503260, 7503259, 7503335.
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactAshley Troiani
484-5531029
Manufacturer Reason
for Recall		Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn July 7, 2026, the firm issued "Urgent: Medical Device Correction" letters to consignees. Customers were informed of the product issue. While the identified 4K UHD LCD monitor may be used with VISERA S, VISERA ELITE III, EVIS X1, and EU-ME3 systems, the firm notes that the affected HDMI or DP connectors are more commonly used with the VISERA S video system center. Its use with the three other systems does not typically involve the affected HDMI or DP connectors. Customers are requested to examine their equipment, looking for the identified monitor model number and serial numbers listed in the customer letter. They should then acknowledge receipt of the letter through the firm's recall web portal. The firm will coordinate repair of the monitors. If customer needs to use the monitor prior to its repair, the firm recommends that a spare unit be available in case issues are encountered with the primary unit during use.
Quantity in Commerce10 units
DistributionWorldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the country of Japan.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GCJ
-
-