Use caution Medical device recall · FDA · Published November 21, 2022

Leica M530 OHX Surgical Microscope May Shut Down Due to Overheating

Leica Microsystems recalls M530 OHX surgical microscopes with serial numbers listed; overheating risk may cause unexpected shutdowns. Affected units should be checked for serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0477-2023Medical device Leica ›

Use caution until it’s fixed

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

Take action

Contact the company

Recalling firmLeica Microsystems, Inc.10 Parkway North blvd ste 300 · deerfield, IL 60089-6622

✎ GovInfoNow plain-language explainer

Leica Microsystems is recalling its M530 OHX surgical microscope systems due to a potential overheating issue that could cause unexpected shutdowns. This risk affects medical professionals using the device during procedures. Read more at govinfonow.com/recall/59304-leica-m530-ohx-surgical-microscope-may-shut-down-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/59304-leica-m530-ohx-surgical-microscope-may-shut-down-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0477-2023

Cite this page

“Leica M530 OHX Surgical Microscope May Shut Down Due to Overheating.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59304-leica-m530-ohx-surgical-microscope-may-shut-down-due-to. Based on FDA recall #Z-0477-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0477-2023%22&limit=1).

The FDA announced on 2022-11-21 that Leica Microsystems, Inc. is recalling its Leica MICROSYSTEMS M530 OHX surgical microscope systems due to a potential power supply overheating hazard. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Leica
Product: Leica MICROSYSTEMS M530 OHX, Part Number 10448737
Units affected: 148

The hazard

The FDA said the power supply may overheat because internal components are overstressing. This overstressing can cause a specific component to fail, resulting in the device unexpectedly shutting down.

Context

GovInfoNow's records show Leica Microsystems, Inc. has 15 other recalls on record since 2017-06-19. Other recent recalls of similar products include OXOS MC2 Portable X-Ray System (2026-06-11), Olympus UHI-4 Insufflation Unit Recall (2026-06-16), and Olympus UHI-2 Insufflation Unit Recall (2026-01-16).

How to tell if you have this one

Check the serial number on your Leica M530 OHX microscope. Affected units have serial numbers listed in the recall notice (e.g., 10622001, 10622002, etc.).

Brand
Leica
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide

Recall number	Product, codes & lots	Quantity
Z-0475-2023	Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system; Serial Numbers: 20522001, 20722001, 21221001, 40222001, 40722001, 70722001, 80522002, 110722001, 150422001, 180322001, 211021001, 260722001, 290422001, 300122001, 270522001. ***EXPANSION 09/08/2023, Serial Numbers: 271222001, 100423002, 31022001, 180623001, 71222001, 210523002, 270922002, 120623002, 100123001, 130623001, 290922002, 300922002, 210223001, 220223001, 251122001, 281122001, 20623002, 60922001, 200822001, 40523001, 40523002, 270922001, 61122002, 20423001, 300523002, 190822002, 300922001, 280922001.	43 units
Z-0476-2023	Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system; ***EXPANSION 09/08/2023 UPDATE a. Premium Part Number 10448950; Serial Numbers: 160222001, 280622001, 50422001, 50422002, 91221001, 180622001, 170622001, 61221001, 130922001, 120623001, 150623001, 81022001, 200623001, 51022001, 61022001. b. Standard Part Number 10448976; Serial Numbers: 120322001, 300122001, 40222002, 301221001, 40122001, 140522001, 151221002, 81221002, 100222002, 300122002, 110322001, 50322001, 90622001, 120422001, 90522001, 100522001, 250122001, 100222001, 171022001, 80922001, 70623001, 30922001, 91022001.	38 units
Z-0477-2023	Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system; Serial Numbers: 10622001, 10622002, 10822001, 20322002, 20522001, 20622001, 30122001, 30322001, 30522001, 30622002, 30722001, 31221001, 40422001, 41221001, 50122001, 60122001, 60522001, 60622001, 70122001, 70322001, 70422001, 70622001, 80422001, 80422002, 80722001, 80822001, 90122001, 90622001, 91221001, 100122001, 100122002, 100322002, 100622001, 100622002, 110222001, 110522001, 110822001, 111221001, 120222001, 120522001, 130122001, 130522001, 130622001, 140122001, 140222001, 140422001, 140522001, 141221001, 151221001, 160122001, 160322001, 160622001, 160622002, 170222001, 170522001, 190322001, 190622001, 200122001, 200522001, 200722001, 210422001, 210622001, 230222001, 230622001, 240122001, 240522001, 260522001, 260722001, 260722002, 261121001, 261221001, 270122001, 270422001, 270422002, 270522001, 270622001, 271121001, 280222002, 280622001, 290522001, 290622001, 291221001, 300322001, 300622002, 301121001, 301221001, 310322001, 310522001. ***EXPANSION 09/08/2023, Serial Numbers: 220523002, 220822001, 131222001, 251122001, 271122001, 100223001, 220423001, 300822001, 30323001, 41222001, 51222001, 91222002, 81222002, 301122001, 180822001, 71222001, 180722001, 220523001, 300523002, 80623001, 30523001, 11122001, 31122001, 81122001, 91222001, 30723001, 211122001, 121222001, 310523001, 40423001, 290323001, 300323001, 141222001, 141222002, 310822001, 40623002, 300922001, 200223001, 90223001, 180523001, 280523001, 240423001, 10623001, 191122001, 61222001, 90623001, 190423001, 70223001, 90223002, 40723001, 130623001, 180423001, 230922001, 260922001, 251022001, 291022001, 200323001, 261022001, 140523001, 160523001.	148 units

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for the serial number on your Leica M530 OHX microscope to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 30 days after the firm started it.

Nov 21, 2022Firm started the recall
Dec 9, 2022FDA classified it Class II
Dec 21, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this microscope?

Check the serial number against the list provided in the recall notice to see if your unit is affected.

Similar recalls

Latest medical device recalls

Keep exploring

More Leica recalls

Link to this recall

<a href="https://govinfonow.com/recall/59304-leica-m530-ohx-surgical-microscope-may-shut-down-due-to">Leica M530 OHX Surgical Microscope May Shut Down Due to Overheating (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0477-2023 (November 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0477-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.