da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the 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 s
Check against the official notice below — it lists the full affected range.
Intuitive Surgical Inc. has recalled 270 Universal Surgical Manipulator units across 100 da Vinci Xi surgical systems (model IS4000) due to high friction points in the manipulators. The defect causes increased arm movement resistance, hesitation, and jerking during use. The affected systems have been distributed worldwide, including throughout numerous U.S. states and countries such as Australia, Brazil, France, Germany, Japan, South Korea, Spain, Sweden, and the United Kingdom.
The recalled units are identified by specific serial numbers beginning with SK, and the UDI is 00886874114216. The source document does not specify a remedy or actions that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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. Quantity: 270 USM units on a combination of 100 unique systems Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.