Recalls / —
—#131686
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.
- FDA product code
- GCJ — Laparoscope, General & Plastic Surgery
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K101077
- Affected lot / code info
- PN 950156-01
Why it was recalled
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 (FDA determination)
Labeling design
Action the firm took
Urgent Medical Device Correction Letters were sent to customers on November 24, 2014.
Recalling firm
- Firm
- Intuitive Surgical, Inc.
- Address
- 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2014-11-21
- Posted by FDA
- 2014-12-19
- Terminated
- 2015-02-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #131686. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.