Lower risk Medical device recall · FDA · Published August 26, 2022

Leica Surgical Microscopes M530 OHX: Inaccurate Illumination with BrightCare Plus Luxmeter

Leica recalls M530 OHX surgical microscopes with specific serial numbers due to potential inaccurate illumination adjustments when used with BrightCare Plus Luxmeter software.

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

🇺🇸 FDA recall #Z-1850-2022Medical device Leica ›

Lower-risk recall

During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Leica is recalling certain M530 OHX surgical microscopes that may have inaccurate illumination adjustments when used with the BrightCare Plus Luxmeter software. This could lead to improper lighting settings during surgery, potentially affecting surgical precision. Read more at govinfonow.com/recall/60122-leica-surgical-microscopes-m530-ohx-inaccurate-illumination-with-brightcare-plus.

Source Summary by GovInfoNow · govinfonow.com/recall/60122-leica-surgical-microscopes-m530-ohx-inaccurate-illumination-with-brightcare-plus · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1850-2022

Cite this page

“Leica Surgical Microscopes M530 OHX: Inaccurate Illumination with BrightCare Plus Luxmeter.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60122-leica-surgical-microscopes-m530-ohx-inaccurate-illumination-with-brightcare-plus. Based on FDA recall #Z-1850-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1850-2022%22&limit=1).

The FDA announced on August 26, 2022, that Leica Microsystems is recalling 115 Leica Surgical Operating Microscopes due to inaccurate illumination adjustments. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Leica
Product: Leica Surgical Operating Microscopes, M530 OHX
Part Number: 10448737

The hazard

Internal testing revealed a component change on the photodiodes inside the M530 Optics Carrier. This results in an inaccurate adjustment of the illumination limits by the software when "BrightCare Plus" with Luxmeter is used.

Context

GovInfoNow's records show Leica Microsystems has 15 other recalls on record since June 19, 2017. Other recent recalls include a November 21, 2022 recall of the Leica Proveo 8 Surgical Microscope for potential overheating and a July 30, 2021 recall of the Leica BOND Antibody CDX2 because it may not perform as specified.

How to tell if you have this one

Check if your microscope has the part number 10448737 and the serial numbers listed in the recall notice. The affected models are Leica M530 OHX surgical operating microscopes.

Brand
Leica
Category
Medical device

FDA recall event · 4 products

All 4 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 distribution.

Recall number	Product, codes & lots	Quantity
Z-1848-2022	Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063; Serial Numbers: 30622001, 41221001, 100522001, 50322001, 60522001, 11221001, 301121001, 20622001, 191121001, 91221001, 61221001, 81221001, 281121001, 291121001, 181121001, 300522001, 71221001, 20322001, 30322001, 60322001, 61221002, 21221001, 241121001, 101221001, 251121001, 31221001, 261121001, 91221002, 101221002, 51221001,	30 devices
Z-1849-2022	Leica Surgical Operating Microscopes, Arveo, Part Number 10448999; Serial Numbers: 210721001, 180721001, 190721001, 121021001, 100821001, 60821001, 90821001, 120821001, 10821001, 80721001, 40821001, 130821001, 290821001, 240821001, 91021001, 180921001, 181121001, 151021001, 190821001, 160921001, 20721001, 50721001, 40921001, 150821001, 160821001	25 devices
Z-1850-2022	Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737; Serial Numbers: 270422001, 160322001, 230222001, 140422001, 100122002, 60721001, 290522001, 310522001, 81121001, 290921001, 130122001, 111021001, 131021001, 171021001, 10622002, 280222002, 51121001, 90821001, 170222001, 170522001, 11221001, 310322001, 260522001, 270522001, 140222001, 270422002, 30122001, 70122001, 271121001, 300322001, 31221001, 41221001, 230222002, 221121001, 70422001, 60122001, 120522001, 90921001, 200122001, 140122001, 100122001, 100721001, 100721002, 110721001, 20522001, 30921001, 261021001, 210422001, 40422001, 240122001, 140721001, 30821001, 50821001, 280721001, 290721001, 300721001, 300821001, 161021001, 160921002, 110222001, 91121001, 141221001, 151221001, 111221001, 301221001, 120222001, 120721001, 160122001, 291221001, 200721001, 91221001, 20921001, 220621001, 131121001, 161121001, 80422001, 240522001, 190821001, 300921001, 61021001, 80721001, 160921001, 10921001, 270122001, 90122001, 10622001, 50122001, 80422002, 211021001, 251021001, 200522001, 110522001, 130522001, 140522001, 110821002, 60522001, 200821001, 210921001, 20322002, 70322001, 100322002, 190322001, 30322001, 301021001, 30522001, 50721001, 261221001, 111121001, 81121002, 261121001, 301121001, 130821001, 60422002, 11221001, 140222002	115 devices
Z-1851-2022	Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950; a. 10448976, Serial Numbers: 120322001, 300122001, 170921001, 301221001, 40122001, 140522001, 151221002, 301021002, 81221002, 100222002, 40222002, 220821001, 300122002, 110322001, 50322001, 180921001, 260821001, 90622001, 120422001, 100522001, 90522001, 210821001, 250122001, 301021001, 100222001; b. 10448950, Serial Numbers: 160222001, 90721001, 50422001, 50422002, 91221001, 160921001, 61221001	32 devices

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify your microscope's serial number against the list provided in the recall notice to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 40 days after the firm started it.

Aug 26, 2022Firm started the recall
Sep 29, 2022FDA classified it Class II
Oct 5, 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 my microscope is affected?

The recall does not include a remedy, so you should check the product details to confirm if your microscope is affected and contact Leica for further guidance.

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Link to this recall

<a href="https://govinfonow.com/recall/60122-leica-surgical-microscopes-m530-ohx-inaccurate-illumination-with-brightcare-plus">Leica Surgical Microscopes M530 OHX: Inaccurate Illumination with BrightCare Plus Luxmeter (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-1850-2022 (August 26, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1850-2022 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.