KUBTEC XPERT 42Recalls & reported problems

Kubtec · Specimen x-ray system · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B619X420), received between Jan 20, 2023 and Jan 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Operating System Version or Upgrade 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.

Most reported problems

Device problems

Operating System Version or Upgrade Problem1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

InjuryJan 20, 2023Operating System Version or Upgrade Problem; Operating System Version or Upgrade Problem
THE COMPANY RECEIVED A MEDWATCH REPORT FROM FDA ON 12/30/2022 THAT WAS FILED BY A HEALTHCARE FACILITY. THE REPORT (# MW5113921) ALLEGED THAT THERE WERE PROBLEMS WITH THE MOZART XPERT 42 SYSTEM DURING SURGICAL CASES. THE REPORT ALLEGED THAT THE SYSTEM STARTED PERFORMING AN AUTOMATIC UPDATE DURING USE RESULTING IN THE SCREENS GOING BLACK, LOSS OF IMAGING AND INABILITY TO IDENTIFY THE LOCATION OF IMPLANTED TISSUE MARKER CLIPS. AS A RESULT THE PATIENT HAD TO RETURN TO HAVE A SECOND SURGERY TO REMOVE CANCEROUS TISSUE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16214026 ↗

Device details

UDI-DI	`B619X420`
Brand	KUBTEC
Model	XPERT 42
Company	Kubtec
Product code	MWP · Cabinet,X-Ray System
Class	Class 2
FDA submission	K071233
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 10, 2022

Device type (GMDN): Tissue specimen x-ray system IVD

An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.

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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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