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Recall Observatory FDA recall evidence

Device product

Chromophare Surgical Light System , REF CH00000001

Z-1506-2024

February 08, 2024

Class II

Product summary

Firm
Stryker Communications
Event
Event 94199
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1506-2024

Official wording

Reason: Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.

Code information: S/N:03857056/ UDI: 07613327296167

Distribution pattern: US: None OUS: Chili

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.