Fluorescence Imaging Procedure Kit — Class II medical device recall Z-0834-2015
Terminated recall by Intuitive Surgical, Inc., reported 2014-12-31, distributed nationwide. The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Ki
| Recall number | Z-0834-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2014-11-21 |
| Classified | 2014-12-19 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-02-20 |
| Distributed | Nationwide (US) |
| Quantity | 1,532 both |
| Model numbers | IS3000 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0834-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.