Intuitive Surgical Recalls da Vinci Xi Suction Irrigator Instruments
Intuitive Surgical is recalling 90 da Vinci Xi Suction Irrigator instruments due to unexpected arm motion with specific software.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of unexpected motion during surgery, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 90 units of the da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument (PN 480299-03), along with specific embedded software (PN 610092-440). The recall involves 15 packs of 6 units each.
The recall was initiated because the company became aware that in specific scenarios involving system software P6, users can experience unexpected motion of a system arm. The instrument is designed for use with the Intuitive Surgical da Vinci Surgical System for delivering fluid, evacuating fluids, retraction, and blunt dissection of tissue.
The affected units were distributed in the United States to one location each in Alabama, Colorado, Kansas, Nevada, and New York, and two locations in Texas. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these units.
The recalled product
- Product
- da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All
Distribution
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