VENTANA HE 600 System 06917259001Recalls & reported problems
Ventana Medical Systems, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630976010), received between Mar 17, 2022 and Jun 24, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Jun 1, 2022Class IIOpen, Classified
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
Z-1374-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash2
- Fire1
- Power Problem1
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.
MalfunctionJun 24, 2022Leak/Splash; Leak/Splash
A CUSTOMER FROM THE UNITED STATES REPORTED THAT THEIR HE 600 SYSTEM EXPERIENCED FLUID OVERFLOW IN THE MIDDLE STAINING MODULE AND FLUID WAS SEEN COMING OUT FROM WHERE THE CARTRIDGES LOAD FOR THE COVERSLIP MODULE. NO ALLEGED HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14801769 ↗MalfunctionJun 17, 2022Power Problem; Power Problem
A CUSTOMER FROM SWITZERLAND REPORTED THAT THEIR HE 600 INSTRUMENT'S PMAD (POWER MANAGEMENT AND DISTRIBUTION) CIRCUIT BOARD HAS BEEN BURNT. NO HARM IS ALLEGED. AN INVESTIGATION IS BEING CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14737211 ↗MalfunctionMar 17, 2022Fire; Leak/Splash; Leak/Splash
A CUSTOMER FROM THE UNITED STATES REPORTED THAT THEIR HE 600 SYSTEM CAUGHT FIRE. IT WAS ALSO REPORTED THAT THE FIRE DEPARTMENT PUT THE FIRE OUT AND DISCONNECTED THE INSTRUMENT FROM THE POWER SOURCE. NO INJURY WAS REPORTED. AN INVESTIGATION HAS BEEN INITIATED AND IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13793254 ↗
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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 · each recall links to the FDA recall notice
- 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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