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U.S. Department of Health and Human Services

Class 2 Device Recall Firefly

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 Class 2 Device Recall Fireflysee related information
Date Initiated by FirmNovember 21, 2014
Date PostedDecember 19, 2014
Recall Status1 Terminated 3 on February 20, 2015
Recall NumberZ-0834-2015
Recall Event ID 69845
510(K)NumberK101077 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductFluorescence 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.
Code Information PN 950156-01
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information ContactMark Johnson
408-523-2100
Manufacturer 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.
FDA Determined
Cause 2		Labeling design
ActionUrgent Medical Device Correction Letters were sent to customers on November 24, 2014.
Quantity in Commerce1532 total both devices
DistributionNationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GCJ
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