SDC4K 0240300100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327562750), received between Aug 15, 2025 and Feb 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026No Display/Image; Output Problem

  IT WAS REPORTED THAT THERE WAS FLICKERING DURING CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316490 ↗
• MalfunctionJan 27, 2026No Display/Image; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE IMAGE DISAPPEARS/REAPPEARS ON THE SCREEN AS IF THE HDMI CABLE (ON THE HDMI IN PORT OF THE SDC4K) WERE BEING PLUGGED IN/UNPLUGGED VERY FREQUENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24195006 ↗
• MalfunctionNov 20, 2025No Display/Image; Electrical Power Problem; No Display/Image; Electrical Power Problem

  IT WAS REPORTED THAT DEVICE TURNED OFF IN THE MIDDLE OF THE CASE CAUSING FULL LOSS OF IMAGE FOR 30 SECONDS. PROCEDURE WAS COMPLETED USING SAME DEVICE AFTER A HARD RESET.

  Patient problems: Insufficient Information

  MAUDE report 23612374 ↗
• MalfunctionOct 23, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE IMAGE GOES BLACK IN A CASE AND THEY HAD TO RESTART THE TOWER. ISSUE WAS NOTICED DURING THE CASE AND THERE WAS FULL LOSS OF IMAGE FOR A MINUTE OR TWO AND IT CAUSED SURGICAL DELAY FOR 1-2 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23374523 ↗
• MalfunctionSep 26, 2025No Display/Image; Output Problem; No Display/Image; Output Problem

  IT WAS REPORTED THAT THE HUB WAS UPDATED TO 5.2 SW BUT THEY ARE EXPERIENCING THESE ISSUES: INABILITY TO CONSISTENTLY TOGGLE INSUFFLATOR FROM CAMERA HEAD. 4K WIRELESS SIGNAL DROP INTRAOPERATIVELY. SDC4K REQUIRE NETWORK CREDENTIALS UPON BOOT UP ¿ NOT CONNECTED TO NETWORK ON BOOT UP. THE MEDICAL PROCEDURE COMPLETED BY PERFORMING A RE-SYNC OF THE 4K WIRELESS OR DIRECT CONNECTED TO WALL PLATE WITH DVI CABLE. DURATION OF FULL LOSS OF IMAGE ON PRIMARY MONITOR - COMPLAINANT NOT AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23159569 ↗
• MalfunctionSep 11, 2025No Display/Image; Output Problem; No Display/Image; Output Problem

  IT WAS REPORTED THAT THE HUB WAS UPDATED TO 5.2 SW BUT THEY ARE EXPERIENCING THESE ISSUES: INABILITY TO CONSISTENTLY TOGGLE INSUFFLATOR FROM CAMERA HEAD. 4K WIRELESS SIGNAL DROP INTRAOPERATIVELY. SDC4K REQUIRE NETWORK CREDENTIALS UPON BOOT UP ¿ NOT CONNECTED TO NETWORK ON BOOT UP. THE MEDICAL PROCEDURE COMPLETED BY PERFORMING A RE-SYNC OF THE 4K WIRELESS OR DIRECT CONNECTED TO WALL PLATE WITH DVI CABLE. DURATION OF FULL LOSS OF IMAGE ON PRIMARY MONITOR - COMPLAINANT NOT AWARE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23032062 ↗
• MalfunctionSep 11, 2025No Display/Image; Output Problem; No Display/Image; Output Problem

  IT WAS REPORTED THAT THE HUB WAS UPDATED TO 5.2 SW BUT THEY ARE EXPERIENCING THESE ISSUES: INABILITY TO CONSISTENTLY TOGGLE INSUFFLATOR FROM CAMERA HEAD. 4K WIRELESS SIGNAL DROP INTRAOPERATIVELY. SDC4K REQUIRE NETWORK CREDENTIALS UPON BOOT UP ¿ NOT CONNECTED TO NETWORK ON BOOT UP. THE MEDICAL PROCEDURE COMPLETED BY PERFORMING A RE-SYNC OF THE 4K WIRELESS OR DIRECT CONNECTED TO WALL PLATE WITH DVI CABLE. DURATION OF FULL LOSS OF IMAGE ON PRIMARY MONITOR - COMPLAINANT NOT AWARE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23032060 ↗
• MalfunctionSep 5, 2025No Display/Image; Application Program Problem; No Display/Image; Application Program Problem

  IT WAS REPORTED THAT THE DEVICE SHUT DOWN DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976663 ↗
• MalfunctionAug 15, 2025No Display/Image; Output Problem; No Display/Image; Output Problem

  IT WAS REPORTED THAT THE DURING THE CASE, THE DEVICE SHUT OFF AND THE SCREEN WENT BLACK. THEREFORE THERE WAS LOSS OF IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22818748 ↗