Company: Intuitive Surgical, Inc,
Date of Enforcement Report 9/24/2008
Class:ll
PRODUCT
Intuitive Surgical DA Vinci Surgical System, Mode; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02. The IS2000 CPG is used during cardiac ablation procedures, Recall # Z-1811-2008
REASON
The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.
RECALLING FIRM/MANUFACTURER
The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide
