FDA recall Z-0477-2022

Haag-Streit USA Inc · Class II · device

Product

OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4

Reason for recall

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

Distribution

US Nationwide distribution in the states of OH, IN.

Key facts

Status
Ongoing
Initiation date
2021-11-03
Report date
2022-01-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mason, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0477-2022