Use caution Medical device recall · FDA · Published October 4, 2019

Ventana HE 600 Histology System: Cleaning Solution Leak Risk

Ventana Medical Systems recalls HE 600 histology instruments with model 06917259001 due to cleaning solution leaking into electrical wiring, risking burned components in lab settings.

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

🇺🇸 FDA recall #Z-2262-2020Medical device Ventana ›

Use caution until it’s fixed

The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.

Take action

Contact the company

Recalling firmVentana Medical Systems Inc1910 E Innovation Park Dr · Oro Valley, AZ 85755-1962

✎ GovInfoNow plain-language explainer

Ventana Medical Systems is recalling HE 600 histology instruments that may leak cleaning solution into electrical wiring, potentially causing burned components. This affects labs using the system for tissue sample processing. Read more at govinfonow.com/recall/66889-ventana-he-600-histology-system-cleaning-solution-leak-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66889-ventana-he-600-histology-system-cleaning-solution-leak-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2262-2020

Cite this page

“Ventana HE 600 Histology System: Cleaning Solution Leak Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66889-ventana-he-600-histology-system-cleaning-solution-leak-risk. Based on FDA recall #Z-2262-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2262-2020%22&limit=1).

The FDA announced on Oct. 4, 2019, that Ventana Medical Systems Inc. is recalling Model Number 06917259001 of the HE 600 instrument due to a cleaning solution leak hazard. The leak can cause electrical shorts and burned components in the device's Coverslipper solvent shield circuit board.

How to tell if you have it

Brand: Ventana
Model Number: 06917259001
UDI: 04015630976010
Product: HE 600 instrument
Units affected: 461

The hazard

According to the FDA, a cleaning solution can leak from the middle staining module and travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This leakage can cause an electrical short and result in burned components.

Context

GovInfoNow's records show Ventana Medical Systems, Inc. has had 7 other recalls on record since Dec. 19, 2017. Other recent recalls of similar products include the Ventana navify Digital Pathology v2.5 Software Image Discrepancy Recall (April 20, 2026), the Ventana anti-CD10 antibody recall (June 27, 2024), and the Ventana PD-L1 (SP142) Assay Recall (Nov. 18, 2022). Other recent recalls of similar products include the ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), the Medline medical procedure kits with Strykeflow 2 irrigation leak risk recall (Dec. 16, 2025), and the Spacelabs Ultraview SL Command Module Software Recall (March 26, 2026).

How to tell if you have this one

Check for model number 06917259001 on the instrument. The product is used in anatomic pathology labs for tissue sample processing.

Brand
Ventana
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Leaks
Inspect the middle staining module for signs of cleaning solution leakage.
Contact Ventana
Reach out to Ventana Medical Systems for further guidance on the recall.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 35 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MD, MI, MA, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI and the countries…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 8 months after the firm started it.

Oct 4, 2019Firm started the recall
Jun 5, 2020FDA classified it Class II
Jun 17, 2020Published 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

Is this recall for home use?

No, this recall applies only to anatomic pathology laboratories and histology facilities in hospitals, clinics, or labs.

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Link to this recall

<a href="https://govinfonow.com/recall/66889-ventana-he-600-histology-system-cleaning-solution-leak-risk">Ventana HE 600 Histology System: Cleaning Solution Leak Risk (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-2262-2020 (October 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2262-2020 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.