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Haag-Streit USA Inc recalls OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Recalled January 19, 2022 · FDA recall Z-0477-2022 · Haag-Streit USA
Hazard
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off · FDA Class II
Units
2 devices quarantined in US
Sold at
US Nationwide distribution in the states of OH, IN.
Description
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Product
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Manufacturer(s)
Haag-Streit USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →