Reported Apr 1, 2015 · Terminated
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. 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, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000
- Material number380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic 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 labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures
- Lot codes and dates
- Material number380663-20
- Serial numbers
1311140532131114003513111404751311140424131114019613111401461311140252131114001013111402891311140578131114043513111403491311140411131114038913111401561311140198131114045213111401861311140554 13111403351311140249
- Material number 380663-21Serial
- numbers
1311140047131114054113111401811311140352 1311140023131114016513111401591311140126131114057113111403971311140130131114031813111401801311140151 13111403751311140428131114052813111402631311140169 13111404431311140537131114054413111404191311140006 131114058313111401731311140154
- Amount recalled
- 167 total affected da Vinci XI systems
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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