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Chromophare Surgical Light System , REF CH00000001

FDA Recall #Z-1506-2024 — Class II — February 8, 2024

Recall #Z-1506-2024 Date: February 8, 2024 Classification: Class II Status: Ongoing

Product Description

Chromophare Surgical Light System , REF CH00000001

Reason for Recall

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

Recalling Firm

Stryker Communications — Flower Mound, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1 unit

Distribution

US: None OUS: Chili

Code Information

S/N:03857056/ UDI: 07613327296167

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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