Z-1784-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2019
- Initiation Date
- January 29, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 433 in total
Product Description
TASE 500 Imaging systems
Reason for Recall
the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
Distribution Pattern
US Nationwide Distribution
Code Information
TASE 500