FDA recall Z-1783-2019

Product

TASE 400 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

US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2019-01-29

Report date

2019-07-03

Voluntary/Mandated

FDA Mandated

Location

Westford, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1783-2019