MalfunctionNTH

ARIOL SL-200 SCANNING SYSTEM

Received Jun 1, 2015 · Event occurred Apr 30, 2015

Report 1419341-2015-00002 · MDR key 4810849

Device

Generic name

None

Manufacturer

Leica Biosystems Richmond, Inc.

Product problems

Device Operates Differently Than Expected

Patient

Not reported

Not Applicable

Narrative

Description of Event or Problem

CUSTOMER REPORTED THE FOLLOWING ISSUES WITH THE ARIOL SL-200 SCANNING SYSTEM: PERSISTENT INCONSISTENCIES IN FRAME ILLUMINATION (CHANGES IN COLOR AND BRIGHTNESS) IN THE SAME SCAN. INCONSISTENCY IN THE COUNT NUMBER OF TARGET EVENTS. VARIABILITY IN OVERALL BRIGHTNESS BETWEEN DIFFERENT SCANS.

Additional Manufacturer Narrative

THE DEVICE IS STILL UNDER INVESTIGATION. FOLLOW UP REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION.