FDA-Device2026-04-08Class IIPROCESSING DEFECT
Stryker CHROMOPHARE Softlit Ring Surgical Light recalled for ceiling cover support risk
What this means
The surgical light assembly in Stryker CHROMOPHARE Softlit Ring systems may not adequately support the weight of the ceiling cover. This could potentially cause the cover to fall. No injuries have been reported.
- Contact Stryker Communications or your equipment representative for inspection or repair
- Do not use the light if you notice any sagging or instability of the ceiling cover
- Check your device reference number (CH00000001) and UDI (07613327296167) to confirm if your unit is affected
The agency's original wording
Hazard
Surgical light assembly may not adequate support the weight of the ceiling cover.
Intended for
Adults
Illnesses reported
None reported
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-1688-2026Want us to check the next one for you?
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