Z-0835-2015Class II

Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi...

Name: Z-0835-2015 Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi...
Creator: Intuitive Surgical, Inc.
Published: 2014-11-21
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2014-11-21 / Terminated / root cause: labeling and UDI

FDA source

Intuitive Surgical, Inc. began a recall of Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical... on 2014-11-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0835-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-21
Posted: 2014-12-19
Terminated: 2015-02-20
Recalling firm: Intuitive Surgical, Inc.
Product: 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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Urgent Medical Device Correction Letters were sent to customers on November 24, 2014.
Quantity in commerce: 1532
Distribution: Nationwide Distribution.
Product codes and lots: PN 950156-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0835-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0834-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-19
Z-0835-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-19

Product code GCJ

K141077Class IIDa Vinci Firefly Imaging SystemIntuitive Surgical, Inc. / cleared 2014-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)