FDA-Device2026-04-08Class II
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Stryker Communications
Hazard
Surgical light assembly may not adequate support the weight of the ceiling cover.
Sold states
Worldwide - US Nationwide distribution.
Affected count
6170 units
Manufactured in
571 Silveron Blvd, Flower Mound, TX, United States
Products
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1688-2026Original summary
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 Surgical light assembly may not adequate support the weight of the ceiling cover. UDI: 07613327296167; All Lots Distribution: Worldwide - US Nationwide distribution. Affected quantity: 6170 units
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