4K Camera Head OLYMPUS CH-S700-XZ-EARecalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Olympus camera head is used with endoscopic video imaging systems. The 26 reports mostly describe communication failures, leaks, and missing or distorted images; there were no deaths or injuries. No recalls name this device, and reports rose sharply to 25 in the last 12 months from 1 in the previous 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: 29
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04953170430268), received between Oct 30, 2025 and Sep 28, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Communication or Transmission Problem11
No Display/Image7
Gas/Air Leak5
Leak/Splash4
Output Problem3
Degraded2
Material Split, Cut or Torn2
Failure to Clean Adequately1

Patient problems

No Clinical Signs, Symptoms or Conditions29

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 28, 2026Poor Quality Image; Gas/Air Leak
The customer reported poor image quality during inspection for use involving an Olympus autoclavable camera head. During the initial evaluation of the returned device, a failed leak test was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917289 ↗
MalfunctionSep 24, 2026No Display/Image; Leak/Splash
The customer reported that the Olympus camera head had no image during inspection for use. During the initial evaluation of the device, it was observed that the device failed the leak test. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884392 ↗
MalfunctionSep 22, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861669 ↗
MalfunctionSep 15, 2026No Display/Image; Communication or Transmission Problem
It was reported that the autoclavable camera head displayed E226 (Incompatible Scope) and a white-out image. The issue was identified during inspection for use. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776665 ↗
MalfunctionSep 10, 2026No Display/Image; No Device Output
The customer reported no light and no image involving an Olympus autoclavable camera head. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50706847 ↗
MalfunctionAug 26, 2026Image Display Error/Artifact; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50455635 ↗
MalfunctionAug 19, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332439 ↗
MalfunctionAug 17, 2026Gas/Air Leak
The customer returned the autoclavable camera head, which is an Olympus asset with no reported complaint. During the evaluation of the device, failed water leak test on cable was observed. The Service Repair Technician indicated that the most likely cause was failed water leak test due to cut on cable. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50274575 ↗
MalfunctionAug 17, 2026Degraded; Communication or Transmission Problem; Gas/Air Leak; Optical Distortion; Material Split, Cut or Torn
The customer reported the camera head had Distorted Image. During the initial evaluation of the device, it was observed that Smashed connector, failed leak test, image quality error (error E238) shown on monitor. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50273469 ↗
MalfunctionJul 28, 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50055640 ↗
MalfunctionJul 16, 2026Gas/Air Leak
THE CUSTOMER RETURNED THE AUTOCLAVABLE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE TECHNICAL ASSISTANCE INDICATES THAT A FAILED LEAK TEST WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25842830 ↗
MalfunctionJul 16, 2026Degraded
THE CUSTOMER RETURNED THE AUTOCLAVABLE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT DAMAGE CABLE INSULATION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841863 ↗
MalfunctionJun 10, 2026Output Problem
THE CUSTOMER REPORTED IR MODE IS NOT WORKING DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS AUTOCLAVABLE CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25462120 ↗
MalfunctionJun 6, 2026Communication or Transmission Problem
THE CUSTOMER REPORTED THAT COMMUNICATION ERROR (E238) OCCURRED EACH TIME THE OLYMPUS AUTOCLAVABLE CAMERA HEAD WAS PLUGGED IN. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25420647 ↗
MalfunctionJun 2, 2026Leak/Splash
THE CUSTOMER RETURNED THE AUTOCLAVABLE CAMERA HEAD WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING EVALUATION OF THE DEVICE LEAKAGE WAS FOUND. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE FAILURE IS DUE TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364676 ↗
MalfunctionMay 29, 2026Gas/Air Leak
THE CUSTOMER RETURNED THE AUTOCLAVABLE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT FAILED LEAK TEST WAS FOUND. IT WAS DETERMINED THAT THE DAMAGED INSULATION CORD NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331449 ↗
MalfunctionMay 19, 2026No Display/Image
IT WAS REPORTED THAT THE AUTOCLAVABLE CAMERA HEAD HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215023 ↗
MalfunctionMay 6, 2026Leak/Splash
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE AUTOCLAVEABLE CAMERA HEAD FAILED THE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095179 ↗
MalfunctionApr 25, 2026Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AUTOCLAVE CAMERA HEAD HAD SCOPE COMMUNICATION ERROR (E226) ON THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24992045 ↗
MalfunctionApr 9, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE AUTOCLAVABLE CAMERA HEAD DISPLAYED A COMMUNICATION ERROR MESSAGE MENTIONING THE CAMERA. THE ISSUE WAS FOUND DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829276 ↗
MalfunctionMar 31, 2026Product Quality Problem
IT WAS REPORTED THAT THE AUTOCLAVABLE CAMERA HEAD DID NOT WORK. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742292 ↗
MalfunctionMar 30, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE AUTOCLAVABLE CAMERA HEAD HAD E238 SCOPE COMMUNICATION ERROR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715133 ↗
MalfunctionMar 10, 2026Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561246 ↗
MalfunctionJan 7, 2026No Display/Image; Output Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED NO IMAGE, ERROR 226 AND FAULTY VIDEO CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23991829 ↗
MalfunctionJan 6, 2026No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THE CAMERA HEAD HAD A SCOPE COMMUNICATION ERROR ERROR E238, NO IMAGE, AND DID NOT WORK AT OUT OF THE BOX FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23976156 ↗

Device details

UDI-DI	`04953170430268`
Brand	4K Camera Head
Model	OLYMPUS CH-S700-XZ-EA
Catalog no.	N6154740
Company	Olympus Medical Systems Corp.
Product code	FET · Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Class	Class 2
FDA submission	K242067, K251336
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	Nov 21, 2025

Device type (GMDN): Endoscope video camera

An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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