FDA-Device2025-10-01Class II
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Hazard
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Sold states
US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.
Affected count
40
Manufactured in
571 Silveron Blvd, N/A, Flower Mound, TX, United States
Products
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2620-2025Want us to check the next one for you?
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