Leica Biosystems CytoVision GSL WinXP->Win7 with current CV version 23GSLXXXKFXUPGRecalls & reported problems
Leica Biosystems Richmond, Inc. · Leica Biosystems CytoVision GSL WinXP->Win7 with current CV version · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849832003762), received between Jan 30, 2024 and Nov 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Loss of or Failure to Bond1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON OCT 8TH THE CUSTOMER REPORTED AN ERROR LOADING & UNLOADING, FAILING TO MOVE TO CORRECT LOCATION ON THE STAGE AND SCANS OF A PREVIOUSLY SCANNED/CAPTURED SLIDE WHEN THE SYSTEM SAYS IT'S ON A SUBSEQUENT SLIDE FOR MATERIAL 23GSLXXXKFXUPG FOR CYTOVISION SN# (B)(6). NO LOSS OF PATIENT DATA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20615549 ↗MalfunctionJan 30, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
ON 04 JAN 2024 THE CUSTOMER HAS REPORTED THE GLUE FAILED ON THE MAGNENT IN THE TRAY, MATERIAL 23GSL902XXX001, WHICH RESULTED IN BREAKING FIVE (5) BONE MARROW SLIDES FOR ONE (1) PATIENT WHILE USING CYTOVISION, MATERIAL 23GSLXXXKFXUPG, SERIAL (B)(6). THERE WAS TISSUE LOSS. IT IS UNKNOWN IF RE-BIOPSY WAS REQUIRED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18609706 ↗
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
- 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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