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M530 OHX 000000000010448737Recalls & reported problems

Leica Microsystems (Schweiz) AG · OHX Stand for M530 - for Leica surgical operating microscope system: M530 OHX · Class 1

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630003579642), received between Oct 30, 2023 and Nov 7, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Electrical /Electronic Property Problem2
  • Device Dislodged or Dislocated1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    LEICA MICROSYSTEMS (B)(6) AG RECEIVED A COMPLAINT FROM USA STATING THAT A M530 OHX HAD A LOSS OF FUNCTION DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23494108 ↗
  • MalfunctionJul 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM CHINA STATING THAT THE HORIZONTAL ARM OF AN M530 OHX CAME LOOSE. THERE WAS NO PATIENT / USER INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22370366 ↗
  • MalfunctionOct 30, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM INDIA STATING THAT A M530 OHX HAD A LOSS OF FUNCTION DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18027465 ↗

Other MICROSCOPE, SURGICAL devices

All MICROSCOPE, SURGICAL devices →

Sources and updates

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