FDAFDA · Food and drugs·Recall number Z-1425-2013
Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
Published June 5, 2013 · Recall initiated: September 23, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
- Lot
- Model numbers: 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-05, 400180-06. 400180-07, 400180-08 and 400180-09.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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