Z-0222-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2014
- Initiation Date
- May 24, 2013
- Termination Date
- November 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Reason for Recall
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
Distribution Pattern
US Distribution in the states of: CA, NE, and NY.
Code Information
MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609