Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 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.
FDA Recall Z-0834-2015 · Posted 2014-12-19
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Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeGCJ
Date Initiated2014-11-21
Date Terminated2015-02-20
Product Quantity1532 total both devices
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.
Firm Action
Urgent Medical Device Correction Letters were sent to customers on November 24, 2014.
Root Cause
Labeling design
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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