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Use caution Medical device recall · FDA · Published May 20, 2020

Leica ARveo and M530 OH6 Microscopes: Possible Surgical Shutdown Risk

Leica recalls ARveo and M530 OH6 surgical microscopes due to voltage changes causing unintended shutdowns during procedures. Affected units have specific serial numbers listed in the recall notice.

🇺🇸 FDA recall #Z-2399-2020Medical deviceLeica ›
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Recalling firmLeica Microsystems, Inc.1700 Leider Ln · Buffalo Grove, IL 60089-6622
✎ GovInfoNow plain-language explainer

What happened, in plain English

Leica is recalling ARveo and M530 OH6 microscope systems because voltage changes might cause them to shut down unexpectedly during surgery. This could interrupt critical procedures and is a serious risk for surgical teams. Read more at govinfonow.com/recall/65114-leica-arveo-and-m530-oh6-microscopes-possible-surgical-shutdown-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65114-leica-arveo-and-m530-oh6-microscopes-possible-surgical-shutdown-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2399-2020

Cite this page

“Leica ARveo and M530 OH6 Microscopes: Possible Surgical Shutdown Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65114-leica-arveo-and-m530-oh6-microscopes-possible-surgical-shutdown-risk. Based on FDA recall #Z-2399-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2399-2020%22&limit=1).

Why it’s dangerous

Voltage fluctuations in the microscope systems can cause unintended shutdowns during surgery. This interruption could halt critical procedures and lead to patient safety risks if not addressed promptly.

Who’s affected

Surgical teams using the Leica ARveo or M530 OH6 microscope systems are most at risk. Patients and medical staff who own or use these specific models may be affected.

How to tell if you have this one

Check for the specific serial numbers listed in the recall notice: M530 OH6 models include OH6-016215, OH6-042317, and other serials starting with OH6-; ARveo models have serials starting with OHA-.

  • Brand
    Leica
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Identify if your microscope has a serial number matching the list provided in the recall notice.

Where it went and when

Where it was distributed

Distributed in 24 states and D.C., and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: not listedMDDelaware: yesDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: yesDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: yesALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic distribution: AL,AR,AZ, CA, CT, DC, DE, FL, IL, KY, LA, MI, MN, MO, NC, NY, OH. OR. TN, TX, UT, VA, WA, WI ,WV. International distribution: Japan” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Connecticut, Delaware, District of Columbia, Florida, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Missouri, New York, North Carolina, Ohio, Oregon, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: May 20, 202012. FDA classified it Class II: Jun 17, 202023. Published in FDA’s Enforcement Report: Jun 24, 202034. FDA terminated the recall: May 13, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-2399-2020 (May 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2399-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA