FDA-Device2025-10-01Class II

Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034

Stryker Communications
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-2620-2025

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