Device product
TASE 400 Imaging systems
Z-1783-2019
Product summary
- Event
- Event 82988
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 433 in total
- Official record key
device-enforcement:Z-1783-2019
Official wording
Reason: the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
Code information: TASE 400
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.