FDA-Device2022-01-19Class II
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Haag-Streit USA Inc
Hazard
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Sold states
US Nationwide distribution in the states of OH, IN.
Affected count
3
Manufactured in
3535 Kings Mills Rd, N/A, Mason, OH, United States
Products
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0478-2022Don't want to check this manually?
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