K-Systems 6.131.812.121Recalls & reported problems

Coopersurgical, Inc. · L126 DUAL, Standard Heat · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937023985), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

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

Electrical /Electronic Property Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 16, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE WORKSTATION WAS INSTALLED ON (B)(6) 2025. DURING INSTALLATION TEST, THE EQUIPMENT FUNCTIONED PROPERLY. ON (B)(6), THE CUSTOMER CONTACTED THE DISTRIBUTOR BECAUSE THE LEFT WORK AREA STOPPED HEATING AND THAT THERE WAS A BURNING SMELL. UPON INSPECTION, TWO SCREWS ON TWO SOLID-STATE RELAYS WERE LOOSE, WITH ONE OF THEM CAUSING SPARKS AND A BURNING SMELL, DANGEROUSLY CLOSE TO ELECTRICAL WIRING. SERVICE TEAM TIGHTENED THE SCREWS AND UNIT IS FUNCTIONING PROPERLY. NO HARM OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION AVAILABLE. (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816252 ↗

Device details

UDI-DI	`00888937023985`
Brand	K-Systems
Model	6.131.812.121
Company	Coopersurgical, Inc.
Product code	PUB · Accessory, Assisted Reproduction, Exempt
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 28, 2024

Device type (GMDN): Laminar airflow hood

A ventilated laboratory enclosure designed to prevent airborne biological contamination of laboratory specimens contained within, and personnel handling the specimen, by creating a barrier with a forced flow of uniform-velocity and parallel-direction air. It is typically a plastic/metallic cabinet-like structure with an open front for product handling and a sash to regulate the opening. Air is typically drawn from the environment into the system by negative pressure created by a line-powered blower; air particles and liquid droplets are removed usually using high-efficiency particulate air (HEPA) filters. Contaminated air is usually exhausted to the outside; also known as an LAF bench.

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All Accessory, Assisted Reproduction, Exempt devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.