Stryker surgical light assembly may not support the ceiling cover weight
Stryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System because the light assembly may not adequately support the weight of the ceiling cover.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: an overhead assembly that may not support the ceiling cover is a fall hazard in an operating room, and no injuries are stated.
Plain-English summary
Stryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System, REF CH00000001. About 6,170 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The surgical light assembly may not adequately support the weight of the ceiling cover.
All lots are affected. The device carries UDI 07613327296167.
Facilities can identify affected systems by the REF and UDI above, and may contact Stryker for further information.
The recalled product
- Product
- Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
- Manufacturer
- Stryker Communications
- Hazard
- structural-failure
- overhead-mounting
- fall-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 07613327296167
- All Lots
Distribution
Distributed nationwide across the United States.
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