Z-1560-2021 Class II Ongoing
FDA device recall Z-1560-2021 was initiated by Haag-Streit USA Inc on April 15, 2021 and is designated Class II. 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). The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- April 15, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
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 Pattern
US Nationwide distribution in the state of WA.
Code Information
Software version 9.3.1