Moderate riskFDA DeviceClass II

Stryker CHROMOPHARE Softlit Ring Surgical Light recalled for ceiling cover support risk

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.

From the FDA notice · Read the official notice ↗ · All Stryker recalls

What to do

  1. Contact Stryker Communications or your equipment representative for inspection or repair
  2. Do not use the light if you notice any sagging or instability of the ceiling cover
  3. Check your device reference number (CH00000001) and UDI (07613327296167) to confirm if your unit is affected

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
6170 units
Illnesses reported
None reported
Manufactured in
571 Silveron Blvd, Flower Mound, TX, United States
Classification
Class II
Recall number
Z-1688-2026

In the FDA's words

Description
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
Hazard
Surgical light assembly may not adequate support the weight of the ceiling cover.

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