ARveo 8x 10449213Recalls & reported problems

Leica Microsystems (Schweiz) AG · ARveo 8x stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8x · Class 1

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 07630802405906), received between May 13, 2026 and May 13, 2026 — 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.

MalfunctionMay 13, 2026Electrical /Electronic Property Problem
LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM PORTUGAL STATING THAT AN ARVEO 8X SHUT DOWN DURING SURGERY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25160967 ↗

Device details

UDI-DI	`07630802405906`
Brand	ARveo 8x
Model	10449213
Company	Leica Microsystems (Schweiz) AG
Product code	EPT · Microscope, Surgical
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Sep 25, 2025

Device type (GMDN): Neurosurgical microscope

A light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures within the neurological fields for surgery, typically the brain or spine or surroundings in the performance of neurological surgical procedures which require high magnification by transmitted light. It will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It is usually fixed.

Other Microscope, Surgical devices

M530 Optics Carrier 000000000010448704
Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL
4 reports
M530 OHX 000000000010448737
Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL
3 reports
PROvido 000000000010448950
Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL
3 reports
M525 F20 000000000010448284
Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL
2 reports
IMAGE1 PILOT TC014
Karl Storz GmbH & Co. KG · MICROSCOPE, SURGICAL
2 reports
PROvido 000000000010448976
Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL
2 reports
ARveo 8 000000000010449063
Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL
1 report
ARveo 8 000000000010449157
Leica Microsystems (Schweiz) AG · Microscope, surgical
1 report

All Microscope, Surgical devices →

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