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
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
- M530 Optics Carrier 000000000010448704Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL4 reports
- PROvido 000000000010448950Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL3 reports
- PROvido 000000000010448976Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL2 reports
- M525 F20 000000000010448284Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL2 reports
- IMAGE1 PILOT TC014Karl Storz GmbH & Co. KG · MICROSCOPE, SURGICAL2 reports
- M530 Optics Carrier 000000000010448700Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL1 report
- 1788 1788210080Stryker Corporation · Microscope, surgical1 report
- ARveo 000000000010448999Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL1 report
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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