Reported May 13, 2020 · Terminated
da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main…
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 · 950 Kifer Rd · Sunnyvale, CA · 94086-5206
Is this the product you have?
- da Vinci Xi Surgical System
- IS4000 - Product UsageThe da Vinci Xi surgical system (IS4000)
- is made of three main componentsthe Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. There are 4 USM per da Vinci Xi surgical system
- Lot codes and dates
- UDI00886874114216
- Device ListingD215864
- Serial Numbers
89 of 89 codes
SK0736SK0856SK1318SK1943SK2228SK2236SK2239SK2240SK2242SK2244SK2248SK2251SK2255SK2256SK2259SK2260SK2261SK2266SK2269SK2270SK2274SK2275SK2281SK2283SK2285SK2294SK2295SK2297SK2300SK2303SK2304SK2305SK2310SK2311SK2312SK2313SK2314SK2315SK2317SK2318SK2320SK2327SK2329SK2330SK2331SK2333SK2341SK2342SK2343SK2346SK2348SK2349SK2350SK2353SK2355SK2356SK2358SK2359SK2360SK2362
- Amount recalled
- 270 USM units on a combination of 100 unique systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.
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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