Intuitive Surgical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0834-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 21, 2014

Date Posted: December 31, 2014

Recall Number: Z-0834-2015

Event ID: 69845

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.

Status: Terminated

Product Quantity: 1532 total both devices

Code Information:

PN 950156-01

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated