Haag-Streit USA Inc recalls OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
- Recall date
- November 3, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0477-2022
- FDA classification
- Class II
- Brand / firm
- Haag-Streit USA Inc
- Sold / distributed
- US Nationwide distribution in the states of OH, IN.
Why it was recalled
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
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