Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
- Company
- Haag-Streit Usa Inc
- Recall Initiated
- April 15, 2021
- Recall Number
- Z-1560-2021
- Firm Location
- Mason, OH
Reason for Recall
Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
Distribution
US Nationwide distribution in the state of WA.
Lot / Code Info
Software version 9.3.1
Root Cause
Software design
Action Taken
On 04/06/2021, Haag-Streit issued an Urgent Medical Device Correction notice to their customer via letter notifying them Eyesuite 9.3.1 software may mix up examination data and patient name when printing or generating a PDF.
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