IMAGE1 X-LINK TC301USRecalls & reported problems

Karl Storz GmbH & Co. KG · CCU,MODULAR,X-LINK,US · Class 2

Quick summary

This Karl Storz Image1 X-Link module is part of an endoscopic video imaging system for gastroenterology and urology procedures. The 25 reports mostly describe video problems during procedures, such as blank screens, flickering or blackouts, disconnections and freezing that needed a reboot. The reports mention no deaths and 1 injury, and no recalls name this device. Reports in the last 12 months were 7, compared with 17 in the prior 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 24
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04048551356562), received between Jan 11, 2024 and Jun 9, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information7
Display or Visual Feedback Problem5
Erratic or Intermittent Display5
Adverse Event Without Identified Device or Use Problem3
Connection Problem2
No Display/Image2
Communication or Transmission Problem1
Optical Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions24
Insufficient Information1

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 9, 2026Connection Problem
IT WAS REPORTED THAT DURING SURGERY IT DISCONNECTED. ERROR MESSAGE "CMOS USB DISCONNECTED - INCOMPATIBLE HEAD" WAS DISPLAYED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25446739 ↗
MalfunctionApr 2, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE VIDEO TOWER DOES NOT RECOGNIZE A VIDEO SIGNAL. TC201 DOES NOT RECOGNIZE THIS X-LINK MODULE, AND THEY ARE ON THE SAME SOFTWARE VERSION. THE ISSUE OCCURRED DURING A CASE. SE SUSPECTS THAT THERE IS CORRUPTED SOFTWARE ON THE DEVICE AS THE TC201 WILL NOT RECOGNIZE THE TC301 MODULE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24771925 ↗
MalfunctionMar 13, 2026Poor Quality Image
IT WAS REPORTED THAT THERE WERE INTERMITTING BLACKOUTS DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24591113 ↗
MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT "THE SYSTEM FROZE UP COMPLETELY DURING A CASE YESTERDAY, IN WHICH THEY HAD TO REBOOT THE SYSTEM". IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT OR INJURY AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 2027009-2025-02404. 2027009-2025-02406.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874045 ↗
MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT "THE SYSTEM FROZE UP COMPLETELY DURING A CASE YESTERDAY, IN WHICH THEY HAD TO REBOOT THE SYSTEM". IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT OR INJURY AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 2027009-2025-02401. 2027009-2025-02403.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874043 ↗
MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT "THE SYSTEM FROZE UP COMPLETELY DURING A CASE YESTERDAY, IN WHICH THEY HAD TO REBOOT THE SYSTEM". IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT OR INJURY AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 2027009-2025-02398 AND 2027009-2025-02400.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874035 ↗
MalfunctionSep 17, 2025Optical Problem; Optical Problem
THE FOLLOWING WAS REPORTED: "CUSTOMER'S IMAGE FLICKERS/ CUTS OUT OR HAS ELECTRICAL INTERFERENCE (IE - PURPLE/GREEN LINES AND/OR STATIC LINES)". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 2027009-2025-01624.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077289 ↗
MalfunctionJul 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT "UNITS ARE GOING BLACK/BLANK WHEN A CAMERA IS PLUGGED IN. CUT OUT IN MIDDLE OF PROCEDURE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666459 ↗
MalfunctionJul 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT "UNITS ARE GOING BLACK/BLANK WHEN A CAMERA IS PLUGGED IN. CUT OUT IN MIDDLE OF PROCEDURE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666435 ↗
MalfunctionJul 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT "UNITS ARE GOING BLACK/BLANK WHEN A CAMERA IS PLUGGED IN. CUT OUT IN MIDDLE OF PROCEDURE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666433 ↗
MalfunctionJul 10, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE GIVING ISSUES WITH IMAGE OUTPUT EXPERIENCING STATICY IMAGE AND SOMETIMES GOES BLANK. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22472983 ↗
MalfunctionJul 10, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE GIVING ISSUES WITH IMAGE OUTPUT EXPERIENCING STATICY IMAGE AND SOMETIMES GOES BLANK. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22472982 ↗
MalfunctionJul 10, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
ACCORDING TO THE EVENT DESCRIPTION "WHEN FLEX XC1 WAS PLUGGED IN, AFTER ABOUT 15 MINUTES THE SCOPE IMAGE BEGAN TO GLITCH AND THEN WENT BACK TO BLUE DASHBOARD THEN BACK TO SCOPE IMAGE GLITCHING AGAIN!" THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD PARTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22472957 ↗
MalfunctionJul 10, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE GIVING ISSUES WITH IMAGE OUTPUT EXPERIENCING STATICY IMAGE AND SOMETIMES GOES BLANK. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22472954 ↗
MalfunctionJun 20, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE TC201 AND TC301 SHOWED NO IMAGE DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE SURGICAL PROLONGATION WAS LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 2027009-2025-01049.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22303023 ↗
MalfunctionMay 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT DURING A CYSTO THERE WAS NO DISPLAY TO THE MONITOR. NO HARM TO PATIENT, USER OR THIRD OCCURRED. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH A DELAY OF 5 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22005994 ↗
MalfunctionApr 1, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT BEFORE THE START OF PROCEDURE (CASE DATE AND TYPE WAS NOT PROVIDED) THE DEVICE HAD NO IMAGE COME UP. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. NO PATIENT INJURY WAS REPORTED. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE IN A DIFFERENT ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21745278 ↗
MalfunctionMar 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A UROLOGY PROCEDURE (CASE DATE WAS NOT PROVIDED) THE DEVICE WAS WORKING ON AND OFF, VERY INTERMITTENT. THERE WAS NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21598406 ↗
MalfunctionFeb 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A PROCEDURE (CASE TYPE AND DATE WAS NOT PROVIDED), DEVICE HAD INTERMITTING BLACKOUTS. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH A BACK-UP UNIT WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407253 ↗
MalfunctionFeb 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A PROCEDURE (CASE TYPE AND DATE WAS NOT PROVIDED), DEVICE HAD INTERMITTING BLACKOUTS. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH A BACK-UP UNIT WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407241 ↗
MalfunctionFeb 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A PROCEDURE (CASE TYPE WAS NOT PROVIDED) ON (B)(6) 2025, DEVICE HAD INTERMITTING BLACKOUTS. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH A BACK-UP UNIT WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407222 ↗
MalfunctionFeb 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE ON (B)(6) 2025 THERE WAS A VERY BAD SIGNAL AND IMAGE DISRUPTION WHEN USING WITH SINGLE SCOPES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 2027009-2025-00163. 2027009-2025-00179.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21361233 ↗
MalfunctionNov 12, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING A CYSTOSCOPY PROCEDURE ON (B)(6) 2024, THE DEVICE GAVE AN ERROR AND NOT RESPONDING. THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A SINGLE-USE SCOPE WITHOUT ANY PATIENT IMPACT. HOWEVER, THIS ISSUE CAUSED A DELAY TO THE PROCEDURE FOR ABOUT 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20667352 ↗
InjuryJan 11, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT DURING AN URETEROSCOPY CASE ON (B)(6) 2023, THE IMAGE WAS FLICKERING BACK AND FORTH BETWEEN THE MENU AND THE MAIN VIEWING IMAGE. THERE WAS NO PATIENT INJURY DUE TO THIS, HOWEVER THEY WERE UNABLE TO COMPLETE THE CASE AND HAD TO RESCHEDULE TO A DIFFERENT DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18499721 ↗

Device details

UDI-DI	`04048551356562`
Brand	IMAGE1 X-LINK
Model	TC301US
Company	Karl Storz GmbH & Co. KG
Product code	FET · Endoscopic video imaging system/component, gastroenterology-urology
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 19, 2025

Device type (GMDN): Endoscopic video image processing unit

An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.