Atlas FDA

Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying

FDA device recall Z-2761-2026 · posted 2026-07-20 · Open, Classified

Recall details

Recalling firm
Olympus Corporation of the Americas
Reason for recall
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Action taken
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.
Root cause
Nonconforming Material/Component
Status
Open, Classified
Product code
GCJ
Quantity affected
10 units
Distribution
Worldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the country of Japan.
Date initiated
2026-07-07
Date posted
2026-07-20
Location
Center Valley, PA

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
4K UHD LCD Monitor OEV321UH (K220069)Olympus Medical Systems Corp.2022-03-09