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Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the d...

FDA Recall #Z-0835-2015 — Class II — November 21, 2014

Recall #Z-0835-2015 Date: November 21, 2014 Classification: Class II Status: Terminated

Product Description

Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Reason for Recall

The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.

Recalling Firm

Intuitive Surgical, Inc. — Sunnyvale, CA

Classification

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

Product Type

Devices

Product Quantity

1532

Distribution

Nationwide Distribution.

Code Information

PN 950156-02

Status

Terminated

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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