inforMED
MalfunctionPSY

GSL 120

Received May 28, 2026 · Event occurred Apr 29, 2026

Report 1419341-2026-00008 · MDR key 25324152

Device

Generic name

Whole Slide Imaging System

Model number

GSL 120

Catalog number

23GSLXXXKFXUPG

Product problems

  • Insufficient Device Problem Information

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON 30 APRIL 2026, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND DOCUMENTED ¿GSL-120 CRASHED BREAKING A SLIDE¿. ON 13 MAY 2026, THE LEICA FIELD TECHNICAL SPECIALIST DOCUMENTED ¿ONLY ONE SLIDE BROKEN, ONE PATIENT AFFECTED. DID NOT HINDER TESTING RESULTS. THERE WERE SUFFICIENT REDUNDANT SLIDES MADE FROM THIS SAMPLE AND CULTURE(S).¿

Additional Manufacturer Narrative

THE ROOT CAUSE FOR THE ¿GSL-120 CRASHED BREAKING A SLIDE¿ COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. AN INSTRUMENT CRASH AND INCORRECT SLIDE LOADING MAY HAVE CAUSED THE SLIDE BREAKING REPORTED BY THE CUSTOMER. THE LEICA FIELD SERVICE TECHNICAL SPECIALIST DOCUMENTED AFTER REPAIRS WERE CARRIED OUT ON THE INSTRUMENT, THE INSTRUMENT RETURNED TO NORMAL FUNCTIONALITY.