Reported Sep 9, 2015 · Terminated
da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- da Vinci Xi Surgical System P4 software;with Xi Stapler
- model number IS4000General
- and Plastic surgeryThe Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures
- Lot codes and dates
- Model number IS4000; Affected da Vinci Xi Surgical System Serial Numbers
196 of 196 codes
SK0036SK0076SK0119SK0156SK0198SK0250SK0288SK0342SK0395SK0425SK0039SK0077SK0120SK0157SK0203SK0254SK0289SK0346SK0398SK0433SK0046SK0079SK0122SK0159SK0206SK0255SK0291SK0347SK0399SK0434SK0047SK0081SK0123SK0160SK0209SK0257SK0292SK0352SK0400SK0437SK0048SK0087SK0127SK0161SK0211SK0259SK0293SK0356SK0401SK0440SK0049SK0091SK0130SK0162SK0212SK0262SK0294SK0358SK0402SK0441
- Model number IS4000; Affected da Vinci Xi Surgical System Serial Numbers
- Amount recalled
- 198 affected devices
Where it was sold
- Nationwide
Why it was recalled
Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
This product could cause temporary or reversible health problems — stop using it.
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