Z-1774-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2013
- Initiation Date
- March 27, 2012
- Termination Date
- July 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 US, 33 foreign
Product Description
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Reason for Recall
When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
Distribution Pattern
Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
Code Information
PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211