FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
- Recall number
- Z-2761-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
- Status
- Open, Classified
- Initiated
- 2026-07-07
- Posted
- 2026-07-20
- Terminated
- not on file
- Reason
- Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
- Root cause
- Nonconforming Material/Component
- Action
- On 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
- 10 units
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the country of Japan.
- Lot, serial or model codes
- Model Number: OEV321UH. UDI-DI: 04953170418723. Serial Numbers: 7503474, 7503477, 7503479, 7503263, 7503264, 7503262, 7503261, 7503260, 7503259, 7503335.
- 510(k) numbers
- ["K220069"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28