Reported Apr 1, 2015 · Terminated
da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical…
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,USM,IS4000
- Material number380647-20 and 380647-22 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 number380647-20
- Serial numbers
1311140430131114058613111400581311140392. 1311140277131114030713111400941311140100131114056913111401021311140421131114009213111400091311140070131114026713111403331311140492131114039113111400571311140294131114050813111405651311140105131114012213111404691311140521131114037813111404561311140230 13111405731311140065131114016413111401941311140511131114029113111403041311140212131114022213111400011311140137131114034413111403811311140341131114053813111401681311140523131114027413111400331311140091 13111402481311140141131114043613111404181311140548 131114032013111401701311140346
- Material number 380746-22Serial
- numbers
1311140486 13111405391311140174131114018313111403271311140347 13111404821311140145131114006613111403021311140477 13111400841311140211131114010313111400831311140050131114048813111403651311140207131114045913111405571311140423131114004513111404401311140231
- 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.
Want the full recall guide?
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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