The Recall Desk
HighFDA (Devices)·Z-1506-2024·Announced 2024-04-17

Chromophare Surgical Light System recalled for insufficient mounting force

Stryker Communications recalls Chromophare Surgical Light Systems due to insufficient mounting force that could compromise the equipment's stability in surgical environments.

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: FDA Class II recall for a surgical light system with a structural stability defect where no injuries or hospitalizations have been reported. This is a risk-of-harm product where injury has not yet been reported, matching the High severity criterion.

Plain-English summary

Stryker Communications is recalling the Chromophare Surgical Light System, model REF CH00000001, due to insufficient mounting force that compromises the stability of the device during use.

The system was distributed outside the United States in Chile. Affected units can be identified by serial number 03857056 and UDI 07613327296167.

Operating room staff and healthcare facilities should be aware of this safety issue. For information on this recall and available remediation options, contact Stryker Communications directly.

The recalled product

Product
Chromophare Surgical Light System , REF CH00000001
Manufacturer
Stryker Communications
Category
Medical Device — Surgical Lighting Equipment
Hazard
  • mounting-failure
  • instability
  • fall-risk

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 (1)

  • S/N:03857056/ UDI: 07613327296167

Distribution

Distribution scope not specified by the agency.

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