da Vinci Xi Surgical System recall
da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console…
Why was da Vinci Xi Surgical System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00886874114216 Device Listing: D215864 Serial Numbers: SK0736, SK0856, SK1318, SK1943, SK2228, SK2236, SK2239, SK2240, SK2242, SK2244, SK2248, SK2251, SK2255, SK2256, SK2259, SK2260, SK2261, SK2266, SK2269, SK2270, SK2274, SK2275, SK2281, SK2283, SK2285, SK2294, SK2295, SK2297, SK2300, SK2303, SK2304, SK2305, SK2310, SK2311, SK2312, SK2313, SK2314, SK2315, SK2317, SK2318, SK2320, SK2327, SK2329, SK2330, SK2331, SK2333, SK2341, SK2342, SK2343, SK2346, SK2348, SK2349, SK2350, SK2353, SK2355, SK2356, SK2358, SK2359, SK2360, SK2362, SK2363, SK2364, SK2365, SK2367, SK2368, SK2369, SK2370, SK2373, SK2374, SK2375, SK2383, SK2385, SK2389, SK2390, SK2393, SK2397, SK2402, SK2404, SK2405, SK2406, SK2412, SK2418, SK2420, SK2437, SK2449, SK2451, SK2452, SK2453, SK2455
- Product
- da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console…
- Recalling firm
- Intuitive Surgical Inc
- Quantity
- 270 USM units on a combination of 100 unique systems
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the United Kingdom.
- Recall date
- May 13, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)